Senior Manager, Statistical Programming

Role: Senior Manager, Statistical Programming supporting clinical trial data analysis and submission for an oncology-focused biotech. Responsibilities: lead programming activities for 1-2 studies, develop and validate CDISC-compliant datasets (SDTM, ADaM), generate analysis outputs, oversee CRO deliverables, ensure regulatory compliance, and improve programming standards. Collaborate with Biostatistics, Data Management, Clinical Ops, and Safety teams; review data and documentation; mentor junior staff; contribute to process improvements. Requirements: Master’s degree in Statistics, Computer Science, or related field; 6+ years in pharma/biotech with strong SAS, GxP, and clinical trial knowledge; regulatory experience, ideally NDA submissions; oncology/hematology experience preferred. HighValue: expertise in statistical programming for clinical trials, CDISC standards, regulatory compliance, and cross-functional collaboration within biotech R&D. WorkSetup: role specifics not detailed; likely hybrid or office-based.