Manager, Clinical Data and Reporting Standards - SDTM Programming (Hybrid)
Core
Develops and governs clinical data and reporting standards (SDTM, ADaM, CDASH) to ensure conformance to CDISC standards and regulatory requirements for AbbVie's clinical trials.
Role type
Manager, Clinical Data Standards & SDTM Programming
Builds
Regulatory submission datasets (SDTM, define.xml), Clinical Study Data Reviewer's Guides, and industry-standardized data collection and reporting frameworks.
Domain
Clinical Research / Biopharmaceuticals / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SDTM programming and specification, ADaM dataset preparation, CDISC standards conformance, regulatory submission documentation, cross-functional standards development, data review rules definition, study-level table/listing/figure standards, safety analysis display standards, CRF design feedback, metadata correction.
Preferred skills
CDASH experience, ADaM/TLF standards experience, active participation in CDISC teams.
Technologies
SDTM, ADaM, CDASH, define.xml, eCRF, TLF
Responsibilities
Define standards for data collection, review rules, SDTM/ADaM mapping, and safety analysis displays; oversee creation of SDTM datasets and regulatory submission guides; provide feedback on CRF design and SDTM trial domains; represent company interests in industry standards projects; drive process improvements for standards.
Seniority
Manager, strategic governance & hands-on technical leadership