Manager - Data Standards, SDTM Programming (Hybrid)

Role: Manage development and implementation of clinical data and reporting standards (CDISC compliance) within AbbVie's pipeline, supporting regulatory submissions and data integrity. Responsibilities: collaborate with cross-functional teams to define data collection, review rules, SDTM/ADaM standards, and ensure consistency; oversee SDTM dataset creation, review trial design domains, and contribute to regulatory documentation (e.g., define.xml). Stay current with industry standards, participate in external standards projects, and improve internal processes. Requirements: MS with 8+ years or BS with 10+ years relevant clinical research experience; expertise in SDTM programming and standards development; experience with SDTM, ADaM, and CDASH preferred. HighValue: clinical data standards, SDTM/ADaM, regulatory submissions, CDISC, industry standards. WorkSetup: not specified.