Manager, Statistical Programming

Role: Lead statistical programming activities for early development pharmaceutical projects, focusing on a specific compound, indication, or therapeutic area. Responsibilities: manage a team of statistical programmers, oversee SAS programming for ADaM datasets and TLFs following CDISC standards, ensure quality and timely deliverables, develop standard macros, and prepare documentation for regulatory submissions. Requirements: MS in Statistics, Computer Science, or related field with 8+ years (MS) or BS with 10+ years relevant experience; proven leadership in statistical programming; expertise in SAS, CDISC standards, and drug development processes; strong communication skills. Preferred qualifications: experience with regulatory filings and cross-functional collaboration. High-Value: early-phase (pre-IND or Phase 1), biologics or small molecules, regulatory documentation, CDISC standards, SAS macro development, cross-team leadership. WorkSetup: not specified; international applicability with standard industry practices.