Manager - Data Standards, SDTM Programming (Hybrid)

Role: Manage development and implementation of clinical data standards (CDISC) such as SDTM and ADaM within AbbVie's clinical trial portfolio, ensuring compliance and supporting regulatory submissions. Responsibilities: collaborate with cross-functional teams to define and document standards for data collection, review rules, SDTM mapping, and reporting; provide feedback on CRF design and SDTM datasets; oversee creation of SDTM datasets, define.xml, annotated CRF, and Study Data Reviewer’s Guides; represent AbbVie in industry standards projects, maintain current knowledge of CDISC and regulatory requirements; drive process improvements. Requirements: MS with 8+ years or BS with 10+ years in clinical research; experience with SDTM programming and standards development; proven track record in preparing data for regulatory submissions. Preferred: experience with CDASH, ADaM, Analysis Results Metadata, TLF standards; active involvement in CDISC initiatives. HighValue: expertise in SDTM/ADaM development, regulatory submission support, industry standards engagement; therapeutic area not specified but applicable to multiple clinical development phases. WorkSetup: not specified.