Manager - Data Standards, SDTM Programming (Hybrid)

Role: Manage clinical data and reporting standards development within AbbVie's pipeline, ensuring conformance to industry standards like CDISC and supporting regulatory submissions. Responsibilities: collaborate with cross-functional teams to define and document standards for data collection, review, and analysis (including SDTM, ADaM, and CDASH), oversee SDTM programming and dataset creation for regulatory filings, and represent AbbVie's interests in industry standards initiatives. Qualifications: MS with 8+ years or BS with 10+ years in clinical research, with expertise in SDTM programming, standards development, and regulatory data deliverables. Preferred: experience with CDASH, ADaM, and industry standards organizations. HighValue: focus on clinical trial data standards, SDTM/ADaM development, regulatory submission support, and pipeline activities. WorkSetup: unspecified; industry-standard expectations for cross-functional collaboration and standards governance.