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

Role: Manage development and implementation of data and reporting standards (CDISC, SDTM, ADaM) to support AbbVie's clinical trial data processes. Responsibilities: define standards for data collection, review rules, mapping, and documentation; ensure consistency across standards; develop training materials; provide feedback on CRF design and SDTM datasets; oversee SDTM dataset creation, define.xml, annotated CRF, and review guides for regulatory submissions; represent AbbVie in industry standards projects; stay current with industry standards and regulatory requirements. Requirements: MS with 8+ years or BS with 10+ years of relevant clinical research experience; strong SDTM expertise; experience leading standards development and regulatory documentation; knowledge of CDISC standards. Preferred: CDASH experience, ADaM, Analysis Results Metadata, TLF standards, active CDISC participation. High-Value: expertise in SDTM/ADaM, regulatory submission support, industry standards development, clinical research in immunology, oncology, neuroscience. Work setup and travel details are not specified.