Manager, Clinical Data and Reporting Standards - SDTM Programming (Hybrid)

Role: Manage development and governance of clinical data standards supporting AbbVie's trials, ensuring compliance with CDISC (SDTM, ADaM, CDASH) and industry best practices. Responsibilities: collaborate with cross-functional teams to define data collection, review, and reporting standards; ensure consistency and proper documentation; develop training materials; review and provide feedback on SDTM datasets, trial design domains, and regulatory submission artifacts; represent AbbVie's interests in industry standards projects; stay current with evolving standards and regulations. Requirements: MS with 8+ years or BS with 10+ years of clinical research experience; expertise in SDTM, experience in standards development for data collection, analysis, or reporting; proven track record in preparing datasets for regulatory submissions. Preferred: experience with CDASH, ADaM, Analysis Results Metadata, TLF standards; active participation in CDISC initiatives. HighValue: expertise in SDTM and CDISC standards; clinical trial data management for regulatory submissions; cross-functional collaboration in biopharma; regulatory compliance focus. WorkSetup: not specified.