✦ Luna Orbit — Data & Analytics

Senior Manager - Data Standards (Hybrid)

at AbbVie

📍 South San Francisco, CA Hybrid Posted March 29, 2026
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Position Details

Type Not Specified
Experience senior
Exp. Years 9+ years
Education MS with 9 years of relevant clinical research experience, or BS with 11 years of relevant clinical research experience
Category Data & Analytics

About this role

Senior Manager - Data Standards responsible for CDISC data and reporting standards development and deployment across AbbVie trials, ensuring conformance to CDISC standards and regulatory submissions.

Key Responsibilities

  • Lead cross-functional standard development
  • Define SDTM/ADaM mapping
  • Oversee Define.xml and CRFs
  • Prepare data for regulatory submissions
  • Educate organization on CDISC standards

Technical Overview

Scope includes defining and documenting SDTM/ADaM standards (CDASH, SDTM, ADaM, Define.xml, CRF design), training material development, and regulatory submission readiness.

Ideal Candidate

The ideal candidate is an experienced data standards professional with CDISC expertise (CDASH, SDTM, ADaM), SAS or R programming, and a track record delivering SDTM/ADaM datasets for regulatory submissions in a clinical trials context.

Must-Have Skills

MS with 9 years of relevant clinical research experienceor BS with 11 years of relevant clinical research experienceExperience leading development of standards for data collectiontabulationanalysis and/or reportingExperience with at least two of the following standards: CDASHSDTMADaMAnalysis Results Metadataor TLF standardsExperience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions

Nice-to-Have Skills

Active participation in CDISC teamsSAS or R programming experienceExperience creating SDTM specifications or training others to use SDTM

Tools & Platforms

CDISC standardsSDTMADaMSDTM define.xmlSASR programming

Required Skills

CDISCCDASHSDTMADaMDefine.xmlannotated CRFClinical Study Data Reviewer’s Guidesregulatory submissionsSDTM mappingADaM mappingdata standardsSASR programming

Hard Skills

CDISC standardsCDASHSDTMADaMAnalysis Results MetadataTLF standardsSDTM mappingADaM mappingSDTM define.xmlCRF designSDTM datasetsregulatory submissionsSASR programmingSDLCtraining materialsclinical trial data

Soft Skills

leadershipcross-functional collaborationtrainingcommunicationproblem solving

Certifications

Preferred

CDISC related trainingCDISC CDASH/SDTM/ADaM certifications

Industry & Role

Industry Healthcare & Medical
Job Function Lead data standards development and governance for clinical trial data
Role Subtype Program Manager
Tech Domains Power BI, Tableau, SharePoint, SQL / PostgreSQL, Microsoft 365

Keywords for Your Resume

CDISCCDASHSDTMADaMDefine.xmlAnnotated CRFClinical Study Data Reviewer’s Guidesregulatory submissionsSDTM mappingADaM mappingTLF standardsSASR programmingclinical datadata standardsclinical trial data

Deal Breakers

Lack of CDISC/CDASH/SDTM/ADaM experience, No regulatory submissions experience, No experience with clinical trial data standards

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