Senior Director, Biostatistics
Dyne TherapeuticsWaltham, Massachusetts, United States · Posted 1 month agoDescription
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, Biostatistics provides strategic, technical, and operational leadership for biostatistical activities across one or more clinical development programs. As a senior statistical leader and cross-functional partner, this role leads statistical activities across the drug development lifecycle, including protocol development, authoring of statistical sections of protocols, development of statistical analysis plans, oversight of statistical analyses and deliverables, interpretation and communication of clinical trial results, and preparation of clinical study reports, regulatory documents, manuscripts, and scientific presentations. The Senior Director provides statistical leadership for global regulatory submissions and health authority interactions, ensuring that clinical development programs are supported by scientifically rigorous, operationally feasible, and innovative statistical strategies aligned with program and corporate objectives. The role requires strong communication skills, scientific leadership, self-motivation, and a strategic and forward-thinking approach. Experience in rare disease drug development is desirable.
This role is based in Waltham, MA.
Primary Responsibilities Include:
- Serve as the senior biostatistics lead and subject matter expert for assigned clinical studies, programs, and development initiatives
- Provide statistical leadership and strategic input into program-level decision making, clinical development plans, study design, endpoint selection, analysis strategies, interpretation of clinical data, and regulatory interactions
- Partner closely with Medical, Clinical Development, Regulatory, Safety, Clinical Operations, Data Management, Statistical Programming, Translational Medicine, Program Management, and other cross-functional stakeholders to ensure statistical strategies support program and corporate objectives
- Lead the statistical design of clinical trials, including sample size determination, randomization and stratification approaches, analytical approaches, interim analyses, multiplicity strategies, sensitivity analyses, subgroup analyses, and missing data considerations
- Contribute to protocol development, including authoring statistical sections and reviewing study design elements to ensure scientific rigor, operational feasibility, and regulatory alignment
- Author, review, or oversee statistical analysis plans and integrated summaries of safety and effectiveness
- Collaborate with Data Management, Clinical Development, Clinical Operations, and Statistical Programming to ensure data collection, eCRF design, and data review activities support planned analyses and regulatory requirements
- Develop or oversee the development of table, listing, and figure shells; provide statistical guidance for SDTM and ADaM dataset development; and review analysis datasets, tables, listings, figures, reviewer guides, and associated documentation to ensure high-quality, compliant, and submission-ready deliverables
- Provide oversight of CROs, consultants, and external vendors to ensure high-quality and timely delivery of statistical services and outputs
- Interpret and communicate clinical trial results to cross-functional teams, senior leadership, external collaborators, and regulatory agencies
- Contribute to clinical study reports, briefing documents, DSURs, regulatory submissions, publications, presentations, and other scientific communications
- Lead statistical strategy and execution for INDs, CTAs, NDAs, MAAs, BLAs, and other global regulatory submissions, including responses to regulatory authority questions
- Prepare for and participate in health authority interactions, including FDA, EMA, and other regulatory agency meetings; address statistical questions and comments from agencies, IRBs, ethics committees, and other external stakeholders
- Contribute to inspection and submission readiness by ensuring statistical documentation, datasets, analysis decisions, and outputs are complete, traceable, consistent, well documented, and filed in the TMF in a timely manner
- Lead or contribute to standardization, process improvement, templates, best practices, and functional standards within Biostatistics and across cross-functional development teams
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