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

Role: Manage development and governance of clinical data and reporting standards supporting AbbVie's trials, ensuring conformance to CDISC standards and industry best practices. Responsibilities: collaborate with cross-functional teams to define standards for data collection, review, and mapping; document assumptions; develop training materials; communicate standards activities; review CRF design and SDTM datasets for regulatory submissions; oversee SDTM dataset creation, define.xml, and annotated CRFs; represent AbbVie's interests in industry standards projects; stay current with CDISC and regulatory requirements; drive process improvements. Requirements: MS with 8+ years or BS with 10+ years in clinical research, extensive SDTM experience, proven record developing standards for data collection, analysis, and reporting, with experience preparing datasets for regulatory submissions. Preferred: CDASH experience, involvement in CDISC teams, familiarity with ADaM and TLF standards. HighValue: emphasis on SDTM/ADaM standards, regulatory submission prep, industry standards engagement, applicable to global clinical trials. WorkSetup: location flexible, no travel specified.