Company Overview

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary

The Senior Director, Medical Affairs Biostatistics provides strategic, technical, and operational leadership for biostatistics across Medical Affairs evidence-generation activities. This role serves as the primary statistical partner to Medical Affairs leadership and is accountable for shaping statistically rigorous, fit-for-purpose evidence strategies that support scientific communication, external engagement, payer and access needs, and lifecycle planning. Areas of responsibility include Phase IV studies, real-world evidence, observational research, secondary and exploratory analyses of clinical development data, investigator-sponsored research, clinical outcomes assessment (PRO/HRQoL), HEOR and value evidence activities, scientific publications, congress presentations, and other Medical Affairs evidence-generation initiatives. The role requires the ability to operate with a high degree of independence, influence cross-functional and senior stakeholders, translate complex statistical concepts into actionable insights, and build scalable processes, standards, and capabilities. Experience in rare disease drug development, preferably neuromuscular disease, is preferred.

This role is based in Waltham, MA.

Primary Responsibilities Include

Strategic Leadership and Evidence Planning

Serve as the senior Biostatistics lead and subject matter expert for Medical Affairs, providing strategic direction, independent statistical judgment, and hands-on statistical leadership
Shape integrated evidence-generation strategies and product-level evidence plans in partnership with Medical Affairs, Clinical Development, HEOR, Value & Access, Regulatory, and Commercial stakeholders
Represent Biostatistics on cross-functional Medical Affairs and evidence-generation teams, influencing strategic decisions and ensuring statistical approaches are scientifically rigorous, practical, and aligned with business and patient needs

Study Design, Analysis, and Evidence Generation

Lead statistical strategy, study design, methodology, and execution for Phase IV, observational, registry, and real-world evidence studies
Lead secondary, exploratory, and post hoc analyses of clinical development data to support Medical Affairs strategy, scientific exchange, publications, congress presentations, payer evidence, and lifecycle planning
Provide statistical expertise to HEOR, Value & Access, HTA, and payer-related activities, including methods for evidence generation, interpretation, and communication to external stakeholders
Provide statistical leadership for clinical outcomes assessment, including PRO/HRQoL analysis, psychometric evaluation, score derivation, endpoint interpretation, and evidence to support publications, payer dossiers, and potential label-enabling activities

Scientific Communication and Cross-Functional Partnership

Lead the statistical strategy for Medical Affairs publications and scientific communications, including manuscripts, abstracts, congress presentations, advisory boards, investigator-sponsored research, and external scientific collaborations
Partner with Clinical Development Biostatistics to leverage complementary expertise, ensure consistency across the product lifecycle, and maintain alignment between development, regulatory, and Medical Affairs analyses
Analyze, interpret, and communicate complex results to cross-functional teams, senior leadership, external collaborators, and non-technical audiences in a clear and actionable manner