Description
AbbVie is hiring a Manager - Data Standards, SDTM Programming (Hybrid) to lead standards development and SDTM programming for clinical research data. The role involves defining data collection, review, SDTM, ADaM, TLF, and study-level standards; preparing SDTM datasets and documentation for FDA and PMDA submissions; reviewing CRF designs and datasets; and supporting regulatory conformance. The position requires a relevant university degree, 8 years of experience with a master’s degree or 10 years with a bachelor’s degree, SDTM programming experience, and experience leading standards development for data collection, tabulation, analysis, or reporting.
