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Associate Director, Statistical Programming

Alkermes
September 08, 2026
Full-time
Remote friendly (Greater Boston)
Worldwide
Clinical Research and Development
Role: Associate Director of Statistical Programming leading study or project level activities within biopharma, supporting neuroscience indications. Responsibilities include designing and developing SAS programs for CDISC-compliant datasets, producing regulatory submission tables, figures, and listings, and leading automation initiatives. The role involves project management, mentorship, cross-functional collaboration with biostatistics, clinical operations, data management, and regulatory teams, and maintaining programming environments. Qualifications: MS or PhD preferred, with over 8 years of experience in pharma/biotech or CRO settings. Skills: expert in SAS, extensive knowledge of CDISC SDTM and ADaM, experience with FDA electronic submissions, proficiency in R/Python a plus. Additional requirements include understanding GCP/ICH guidelines, strong interpersonal and organizational skills, attention to detail, and effective communication. Preferred: neuroscience experience, SAS LSAF knowledge. Work setup: hybrid (60% office, 40% remote) at Waltham, MA, with onsite presence at least 3 days/week.