Manager - Data Standards, SDTM Programming (Hybrid)
Core
Develop and govern clinical data standards (CDISC SDTM, ADaM, CDASH) and execute SDTM programming to support regulatory submissions for AbbVie's clinical trials.
Role type
Manager, Clinical Data Standards & SDTM Programming
Builds
Regulatory submission datasets (SDTM, define.xml, annotated CRF), standard documentation, and training materials
Domain
Clinical Research / Biopharmaceuticals / CDISC Standards
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SDTM programming, clinical research standards development, regulatory submission preparation, cross-functional team leadership, data governance
Preferred skills
CDASH experience, ADAM/TLF standards knowledge, CDISC team participation
Technologies
CDISC SDTM, ADaM, CDASH, define.xml
Responsibilities
Define data collection, review rules, and mapping standards; provide feedback on CRF design and SDTM datasets; oversee creation of submission-ready datasets and documentation; represent company interests in industry standards projects
Seniority
Manager, hands-on IC with strategic oversight