Associate Director, Data Standards & Statistical Programming

Position Summary: The Associate Director of Data Standards & Statistical Programming (DSSP) will be responsible for planning and tracking statistical programming activities at both program and study levels. This includes coordinating tasks across multiple studies, ensuring CDISC standards implementation, and designing and validating computer programs for clinical data analysis. The role involves defining departmental standards and SOPs, overseeing clinical data listings, tables, figures, and Define.xml files. Responsibilities: • Manage all statistical programming activities at program and study levels. • Oversee programmer work to ensure high-quality results. • Act as a liaison between statistical programming, data management, and biostatistics. • Develop SOPs, work instructions, and processes. • Perform statistical analysis for clinical trial interpretation. • Create CDISC datasets, SAS transport files, Define.xml, Pinnacle 21 reports, and reviewer guides. • Generate safety and efficacy tables, listings, and graphs using SAS. • Develop dataset specifications and review TLF shells. • Review data management and validation plans. • Contribute to statistical analysis plans and provide expertise in protocol development. • Resolve data inconsistencies. • Automate processes to improve programming efficiency. Requirements: • MS in mathematics, statistics, computer science, or equivalent. • 12+ years of statistical programming experience in the bio-pharma industry using SAS. • 8+ years of experience with CDISC SDTM and ADaM standards. • 4+ years of experience in oncology clinical trials, using RECIST. • Experience developing datasets and outputs for ISE/ISS in NDA filings. • 4+ years of experience in a fast-paced small or medium biotech environment. • Strong knowledge of SAS programming. • Knowledge of R or Python is a plus.