Senior Statistical Analyst - Programmer (Hybrid)

Job Overview The role of the Senior Statistical Analyst is to perform statistical programming activities for all assigned Phase I‑IV clinical studies sponsored by AbbVie and its partners. This position performs statistical programming for clinical studies, integrated summaries, and in support of responses to requests from regulatory authorities. It can serve as a study lead for an assigned study. Responsibilities Leads the statistical programming activities and provides programming and documentation support for multiple studies with high quality. Reviews statistical analysis plans for all assigned studies and integrated summaries in conjunction with the program lead and provides comments to the study biostatistician. Creates ADaM data set specifications and the data set for all assigned studies and integrated summaries. Ensures study analysis is consistent with standard templates and specifications. Contributes to submission support and supports urgent regulatory agency requests. Follows timelines for assigned study tasks. Coordinates own task assignments. Participates in a Statistical Programming process improvement initiative. Manages timelines and ensures good communication with CROs/FSPs, internal programmers, statistics, data management, medical writing, regulatory publishing, and clinical operations. Oversees programming tasks for a single study. Conducts high-level review of deliverables provided by CRO/FSP to ensure good quality and accuracy. Minimum Qualifications Degree in Statistics, Mathematics, or Engineering. 6+ years of relevant experience (with MS) or 8+ years of relevant experience (with BS). Experience with SAS programming related to drug development. Experience with regulatory filings. Experience adhering to CDISC standards and creating and reviewing ADaM specifications. Preferred Qualifications Knowledge of R or AI is not required but can be a plus. Other Required Skills In-depth understanding of SAS programming concepts and techniques related to drug development. Fundamental understanding of CDISC Standards. Fundamental understanding of the drug development process. Ability to communicate clearly both orally and in writing. Ability to accurately estimate effort required for study‑related programming activities. Benefits Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees. Eligibility to participate in short‑term incentive programs. EEO Statement AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled. Additional Information U.S. & Puerto Rico only: to learn more, visit U.S. & Puerto Rico applicants seeking a reasonable accommodation: click here to learn more: #J-18808-Ljbffr Allergan