Senior Director, Medical Affairs Biostatistics

The posting, as Dyne Therapeutics wrote it

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 re search, 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, scien

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management, quality oversight, timelines, and deliverables

• Demonstrated experience leading and developing statisticians through direct management, matrix leadership, technical mentorship, or functional capability-building
• Ability to independently prioritize and manage multiple concurrent priorities and deliverables in a fast-paced, matrixed biotechnology environment
• Strong analytical judgment and problem-solving skills, with the ability to work through ambiguity, anticipate risks, and recommend practical, scientifically sound solutions
• Excellent verbal and written communication skills, with the ability to effectively communicate complex statistical concepts to technical and non-technical audiences, including senior leaders and external stakeholders
• Experience in rare disease, preferably neuromuscular disease, is preferred
• Interest in and basic understanding of biology and biological processes, including ASO and siRNA modalities

#LI-Onsite
MA Pay Range
$265,000 — $300,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.