Senior Director, Medical Affairs Biostatistics

The role

The Senior Director, Medical Affairs Biostatistics provides strategic, technical, and operational leadership for biostatistics across Medical Affairs evidence-generation activities. This role shapes evidence strategies for Phase IV studies, real-world evidence, and scientific communications.

What you will do

• Provide strategic direction and independent statistical judgment for Medical Affairs
• Shape integrated evidence-generation strategies and product-level evidence plans
• Lead statistical strategy, study design, and execution for Phase IV, observational, registry, and real-world evidence studies
• Lead secondary, exploratory, and post hoc analyses of clinical development data
• Provide statistical leadership for clinical outcomes assessment
• Lead statistical strategy for Medical Affairs publications and scientific communications
• Partner with Clinical Development Biostatistics to ensure consistency across the product lifecycle
• Develop, review, and execute analysis plans and associated documentation
• Provide oversight of CROs, consultants, and external vendors
• Manage, mentor, and develop direct reports and other statistical colleagues

Required qualifications

• PhD in Statistics, Biostatistics, or a related quantitative discipline with 10+ years of relevant pharmaceutical, biotechnology, or health-related industry experience; or MS with 12+ years of relevant
• Demonstrated experience leading the design, analysis, interpretation, and reporting of analyses within Medical Affairs, including Phase IV, observational, registry, and real-world evidence studies
• Experience supporting scientific publications, congress presentations, investigator-sponsored research, and external scientific engagement
• Strong expertise in statistical methodology relevant to observational and real-world research
• Advanced SAS programming skills
• Ability to perform, review, and oversee statistical analyses
• Experience overseeing CROs, consultants, and external vendors
• Demonstrated experience leading and developing statisticians through direct management, matrix leadership, or technical mentorship
• Ability to independently prioritize and manage multiple concurrent priorities in a fast-paced, matrixed biotechnology environment
• Strong analytical judgment and problem-solving skills
• Excellent verbal and written communication skills
• Interest in and basic understanding of biology and biological processes, including ASO and siRNA modalities

Nice to have

• Experience in rare disease, preferably neuromuscular disease
• Experience with R
• Familiarity with contemporary tools and approaches for real-world data analysis

About the company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for other diseases.