Manager/Senior Manager of Statistical Programming

Role: Manager/Sr Manager of Statistical Programming, overseeing programming efforts for multiple clinical trials supporting biopharma development in dermatology, specifically chronic skin diseases like psoriasis. Objectives include ensuring high-quality, timely, and compliant statistical deliverables for clinical studies, with a focus on regulatory-readiness and process efficiency. Responsibilities involve leading statistical programming activities, validating deliverables, overseeing CRO collaborations, and working with Data Management and Biostatistics teams on SDTM and ADaM specifications. Qualifications require a BS/MS in life sciences, computer science, or statistics, 5+ years in programming roles, with at least 2+ years leading clinical programming teams. Deep expertise in SAS, CDISC standards, and regulatory guidelines (FDA, EMA, ICH) is essential; R programming skills are a plus. Experience with biologics or antibody therapeutics and regulatory submission processes (e.g., NDA) is highly desirable. The role demands leadership, cross-functional collaboration, and experience managing external vendors. The position is remote or hybrid (Waltham, MA), with some travel expected. Salary range: $146,000 to $187,000 depending on seniority and experience.