Associate Director, Statistical Programming

Responsibilities

• Lead and oversee statistical programming activities across multiple clinical trials and studies
• Collaborate with biostatisticians, data managers, and clinical operations to define programming strategies
• Develop, validate, and maintain analysis datasets (CDISC standards), tables, listings, and figures (TLFs)
• Provide technical leadership for regulatory submissions (FDA, EMA) and eCTD deliverables
• Coordinate and oversee vendor/FSP statistical programming activities
• Build and promote reusable tools, macros, and automation solutions
• Mentor junior programmers and provide technical guidance to teams

Requirements

• Bachelor’s degree required; advanced degree in statistics, biostatistics, or related field preferred
• Minimum of 10 years of statistical programming experience in pharmaceutical or biotechnology industries
• Advanced proficiency in SAS
• Strong knowledge of CDISC standards (SDTM, ADaM)
• Demonstrated experience supporting or leading regulatory submissions
• Strong leadership and project management skills

Preferred Qualifications

• Experience with R or Python
• Experience coordinating vendor/FSP statistical programming activities

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, targeting muscle and the central nervous system (CNS) to address the root cause of disease.