ValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read LessValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read LessValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read LessValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read LessValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read LessValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read LessValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read LessValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read LessValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read LessValueSpire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence. We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission. Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions. We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADaM standardization work. You will help build an AI-native clinical data platform that generates SDTM, ADaM, and submission-ready datasets directly from clinical documents
You will be responsible for the end-to-end data standards lifecycle: from protocol interpretation through SDTM/ADaM dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work - built SDTM domains from raw data, written ADaM derivation specifications, coded against MedDRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review. You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
ResponsibilitiesSDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities
• Lead SDTM mapping, specification design, review, validation, and issue resolution
• Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains)
• Create and maintain SDTM annotated CRFs (aCRF)
• Collaborate with programming leads to create SDTM programming specifications and integrate non-eCRF data (central lab, bio-analytical, biomarker assay data)
• Provide guidance on CRF annotation strategies, SDTM implementation decisions, and SDTMIG interpretation
• Define ADaM derivation specifications for core analysis datasets: ADSL, ADAE, ADLB, ADVS, ADEX, ADCM, and other analysis-ready datasets as required
• Author and validate standard derivation patterns including baseline flagging (ABLFL), visit windowing (AVISIT/AVISITN), change from baseline (CHG, PCHG), and analysis record flags
• Define OCCDS derivation logic including treatment-emergent flags (TRTEMFL), occurrence flags (AOCCzzFL), and medical coding integration
• Specify population flag derivation rules (SAFFL, ITTFL, PPROTFL) aligned to protocol and SAP definitions
• Serve as senior biostatistical reviewer for SDTM and ADaM deliverables
• Own the controlled terminology strategy: CDISC CT, MedDRA, WHODrug, LOINC, UCUM, SNOMED
• Define sponsor dictionary governance and application rules across studies
• Manage extensible codelist decisions and sponsor-defined term resolution
• Ensure CT version consistency across all domains and datasets within each study
• Generate and review Pinnacle 21 / CORE conformance reports at critical milestones
• Provide remediation guidance and comments to programming teams on validation findings
• Conduct quality control reviews, peer reviews, and ensure compliance with CDISC standards, SOPs, and regulatory guidelines
• Perform cross-field consistency checks and data reconciliation across domains and datasets
• Review and prepare SDTM and ADaM eSubmission packages (XPT and Dataset-JSON formats)
• Author or review Define.XML for both SDTM and ADaM
• Author or review Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
• Support regulatory submissions including eCTD packages and audit readiness activities
• Ensure compliance with 21 CFR Part 11, ICH guidelines, and FDA/EMA technical conformance criteria
• Perform complex data integration, reconciliation, pooling, and transformation activities across multiple studies
• Develop, validate, and maintain programs for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) as needed
• Design reusable macros, utilities, and standard templates to improve productivity
• Support ISS/ISE deliverables and cross-study data standardization
• Serve as the go-to resource for SDTM and ADaM questions across the organization
• Act as primary data standards contact for assigned studies, managing timelines, risks, and issue resolution
Required Qualifications
• 8+ years of hands-on experience with CDISC SDTM and ADaM standards in pharmaceutical, biotech, or CRO environments
• Demonstrated experience as an SDTM Lead or SME across Phase I-IV clinical trials
• Deep expertise in SDTM mapping, controlled terminology application, and domain programming across all major observation classes
• Strong experience developing and validating ADaM datasets including ADSL, ADAE, ADCM, ADLB, ADVS, and other analysis-ready datasets
• Proficiency in SAS programming (Base SAS, SAS Macros, PROC SQL, SAS ODS) for SDTM/ADaM development, validation, and TFL generation
• Experience with Pinnacle 21 (Enterprise or Community) and/or CDISC CORE for conformance validation
• Hands-on experience with Define.XML creation, annotated CRF development, and reviewer's guide authoring (cSDRG, ADRG)
• Experience preparing eCTD submission packages and supporting regulatory interactions (FDA, EMA)
• Strong understanding of MedDRA, WHODrug, LOINC, and other medical coding dictionaries
• Excellent analytical, communication, and cross-functional stakeholder management skills
Preferred Qualifications
• Familiarity with the pharmaverse ecosystem (admiral, sdtm.oak, metacore) or R-based clinical programming
• Experience with Dataset-JSON format and CDISC's evolving standards roadmap
• Exposure to automation or AI-driven workflows
• Experience with ISS/ISE deliverables and integrated cross-study data packages
• Experience working in early-stage or high-growth environments where you have built processes from scratch
• Familiarity with USDM (Unified Study Definitions Model) and digital protocol concepts
Why Join ValueSpire
• Your standards expertise will shape a product, not just one study - every decision you make scales across the platform
• Small, senior team where your work directly impacts the company trajectory
• Remote-first culture with flexibility and autonomy
• Direct collaboration with the founding team and access to real customer engagements
How to Apply
Send your CV and a brief note describing your CDISC standards experience. We are looking for people who have built SDTM and ADaM packages end-to-end, know what a clean Pinnacle 21 report looks like, and understand why data standardization is the hardest part of getting a drug approved.
Read Less