Description
AbbVie is hiring a Manager, Clinical Data and Reporting Standards (CDARS) to develop and govern clinical data and reporting standards for its portfolio of clinical trials. The role focuses on CDISC, SDTM, ADaM, CDASH, and industry best practices; it includes defining standards, supporting CRF and dataset design, reviewing SDTM and ADaM conformance, preparing datasets and documentation for FDA and PMDA submissions, developing training materials, and representing AbbVie in industry standards projects. Applicants need an MS with 8 years of relevant clinical research experience or a BS with 10 years, along with SDTM, standards-development, and regulatory-submission experience. The position offers medical, dental, and vision insurance, a 401(k), paid time off, and eligibility for long-term incentive programs.
