Manager - Data Standards, SDTM Programming (Hybrid)

Role: Senior professional in clinical data standards, focusing on developing and implementing data and reporting standards aligned with CDISC (SDTM, ADaM, CDASH) to support AbbVie's clinical trial portfolio. Responsibilities include collaborating with cross-functional teams to define standards for data collection, review rules, SDTM mapping, and study-level analyses; ensuring consistency and proper documentation; developing training materials; and contributing to pipeline data review, SDTM dataset creation, and regulatory submission documentation. The role also involves industry standards engagement, process improvement, and staying current with regulatory requirements. Qualifications: MS with 8+ years or BS with 10+ years of relevant clinical research experience; experience with SDTM programming, standards development, and regulatory submission documentation is required. Preferred skills include CDASH experience, familiarity with ADaM and analysis metadata, and active participation in industry standards committees. HighValue: expertise in SDTM and ADaM for clinical data management and reporting, supporting regulatory submissions (FDA, PMDA), and enhancing data standards within biopharma clinical development. Collaboration with study teams, regulatory, and industry groups is essential. WorkSetup: not specified; likely office-based or hybrid given industry norms.