Associate Director of Statistical Programming

A clinical-stage biopharmaceutical company focused on developing precision medicines in oncology is seeking an Associate Director of Data Standards & Statistical Programming. The organization is advancing a diverse pipeline of targeted therapies and has established multiple strategic collaborations while retaining control of several of its most advanced clinical programs. The team is passionate about innovation, collaboration, and delivering therapies to patient populations with high unmet medical needs. Position Summary The Associate Director will be responsible for: • Planning and tracking statistical programming activities, including SAS macro development at program and study levels. • Coordinating across multiple studies, collaborating with CROs, Biostatistics, and Data Management on key deliverables. • Ensuring the latest CDISC standards are implemented and followed. • Designing, developing, and validating computer programs to analyze clinical data. • Defining departmental standards and SOPs as needed. • Overseeing and managing workflows for clinical data listings, summary tables, figures, and Define.xml files. • Mentoring junior programmers on assigned projects. Key Responsibilities • Manage statistical programming activities at both program and study levels. • Oversee the work of programmers to ensure accuracy and quality. • Act as a liaison between statistical programming, data management, and biostatistics for optimal workflow. • Develop SOPs, work instructions, and processes to ensure high-quality results. • Perform statistical analyses to support interpretation of clinical trial results. • Create SDTM, ADaM, SAS transport files, Define.xml, Pinnacle 21 reports, and reviewer guides for electronic submissions. • Generate safety and efficacy tables, listings, and graphs using SAS tools. • Develop dataset specifications and review TLF shells. • Review data management plans, data validation plans, and edit check specifications. • Contribute to statistical analysis plans and provide expertise in protocol development, CRF design, and data collection. • Identify and resolve data inconsistencies. • Automate processes to improve programming efficiency and quality. Requirements • MS (or equivalent) in mathematics, statistics, computer science, or related field. • 12+ years of statistical programming experience in the biopharma industry, using SAS to analyze Phase I–III clinical trial data. • At least 8 years of experience with CDISC SDTM and ADaM standards. • Minimum of 4 years’ oncology clinical trial experience, including RECIST endpoints. • Experience leading statistical programming for NDA filings and integrated summaries (ISE/ISS). • At least 4 years working in a fast-paced small or medium biotech environment. • Strong SAS programming/statistical background (Base SAS, Macros, Graph, Stat). • Knowledge of R and/or Python a plus.