Manager, Statistical Programming

Role: Manager of Statistical Programming supporting late-stage clinical trials for rare metabolic disorders, with a focus on hypoglycemia related to hyperinsulinism and tumor-associated hypoglycemia. Responsibilities: deliver study-level programming using SAS and R, develop and validate CDISC SDTM and ADaM datasets, generate TLFs and analysis reports, oversee CRO or internal programmers, ensure regulatory compliance, and contribute to programming standards and documentation for electronic submissions. Collaborate with Clinical Operations, Data Management, Safety, and Biostatistics teams throughout trial phases. Requirements: BS/BA in Statistics, Computer Science, or related field; 8+ years pharma/biotech/CRO experience (6+ with MS); strong SAS (Base, Macro, SQL, ODS) and working proficiency in R, including data manipulation and reporting; experience with CDISC standards, GCP, and ICH guidelines; prior supervisory or lead programmer experience. Preferred: R Shiny application development, Python familiarity, and experience with regulatory submissions. HighValue: Rare disease space, late-stage clinical development, focus on hyperinsulinism and neuro-oncology disorders, GxP compliance, cross-functional teamwork, and technical expertise in clinical data standards. WorkSetup: Not specified; salary range approximately $160K-$195K plus bonus and benefits.