Senior Director, Biostatistics

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 and follow us onXLinkedInandFacebook.

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
• Manage mentor and develop direct reports and other statistical colleagues fostering technical excellence collaboration accountability and a high-performing team environment

Education and Skills Requirements:

• Ph.D. (or Masters) in Statistics Biostatistics or a related quantitative discipline with at least
• 12 years of pharmaceutical or biotechnology industry experience
• Demonstrated experience leading the design analysis interpretation and reporting of clinical trials across multiple phases of development
• Experience supporting regulatory interactions and major health authority submissions including NDAs BLAs MAAs or equivalent global submissions and responding to regulatory authority questions
• Deep understanding of statistical methodology for clinical development including design estimation inference missing data and adaptive methods
• Knowledge of FDA EMA ICH and other applicable regulatory guidelines
• Strong understanding of CDISC standards including SDTM and ADaM
• Advanced SAS programming skills are required; experience with R is a plus. 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
• Demonstrated ability to influence program strategy and cross-functional decision making through communication of statistical recommendations and data insights
• Ability to independently prioritize and lead multiple studies programs and development activities simultaneously
• Strong analytical judgment and problem-solving skills with the ability to work through ambiguity assess risk and recommend practical scientifically sound solutions
• Excellent verbal and written communication skills with the ability to effectively communicate complex statistical concepts and clinical results to technical and non-technical audiences
• Experience in rare disease or neuromuscular disease is preferred
• Interest in and basic understanding of biology and biological process including ASO and siRNA

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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.