Associate Director, Statistical Programming

Role: Associate Director, Statistical Programming overseeing multi-study clinical trial programming in neuromuscular diseases, including DMD and DM1. Responsibilities: lead and coordinate statistical programming activities, ensure quality and regulatory compliance, develop analysis datasets (CDISC standards), review SAPs, perform complex analyses using SAS/R, support regulatory submissions (e.g., FDA, EMA eCTD), oversee vendor/FSP activities, promote automation and standardization, and mentor junior staff. Qualifications: bachelor’s degree (advanced preferred) in statistics, biostatistics, or related field; at least 10 years of pharmaceutical/biotech programming experience; advanced SAS proficiency; knowledge of R, Python preferred; strong understanding of CDISC (SDTM, ADaM), regulatory standards, and submission process; leadership and project management skills. High-Value: experience supporting regulatory submissions, multi-study coordination, and vendor management. Work Setup: based in Waltham, MA, with a focus on process innovation and departmental strategy.