Associate Director, Statistical Programming

Role: Associate Director of Statistical Programming supporting drug development for CNS disorders, focusing on data quality, regulatory compliance, and cross-functional collaboration. Responsibilities: oversee SAS programming for SDTM, ADaM datasets, tables, listings, figures; ensure timely, high-quality outputs for regulatory submissions and study reports; lead programming activities and validation; manage CRO/vendor relationships; align activities with CDISC, ICH, FDA, EMA standards; partner with biostatistics, data management, clinical teams to resolve issues and enhance processes. Requirements: Master’s in statistics, computer science, or related field; 8+ years of biotech/pharma statistical programming experience; expert in SAS, familiarity with R/R Shiny desirable; strong knowledge of CDISC standards, FDA/ICH regulations; proven CRO management skills; excellent communication and collaboration abilities. High-Value: biopharma, CNS indications, early to late-phase clinical trials, regulatory submissions (NDA/BLA, MAA), GxP compliance, cross-functional interfaces. WorkSetup: hybrid (3 days in Burlington, MA), with potential for remote work.