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

Role: The Manager, Clinical Data and Reporting Standards (CDARS), develops and implements data and reporting standards supporting AbbVie's clinical trial portfolio, ensuring compliance with CDISC standards and industry best practices. Responsibilities: define and document standards for data collection, review rules, SDTM/ADaM mapping, and study-level analyses; provide feedback on CRF design and SDTM datasets; oversee creation of SDTM datasets, define.xml, annotated CRF, and submission guides; stay current with industry standards and contribute to industry projects; foster standards development and training across the organization. Requirements: MS with 8+ years or BS with 10+ years of clinical research experience; extensive SDTM knowledge; experience leading standards development and regulatory data submissions; proficiency in SDTM and ideally CDASH and ADaM. High-Value: focus on clinical data standards in biopharma, supporting regulatory filings (FDA, PMDA); experience with SDTM and ADaM datasets; involvement in pipeline data review, conformance troubleshooting, and industry standards development. WorkSetup: not specified; location and travel details not provided.