Senior Director, Biostatistics

BioSpace; Waltham (MA); On-site; USD 250,000 - 290,000; Full time

Job summary

Dyne Therapeutics in Waltham, MA seeks a Senior Director, Biostatistics to lead statistical activities across one or more clinical programs. You will guide protocol development, analysis plans, trial designs, and regulatory submissions while partnering with medical, regulatory, safety, and clinical operations teams.

The role requires a Ph.D./Masters in statistics with 12+ years in pharma/biotech, strong SAS programming, CDISC expertise, and experience overseeing CROs.

Qualifications

• Ph.D. or Masters in Statistics, Biostatistics, or a related quantitative discipline.
• 12+ years of pharmaceutical or biotechnology industry experience.
• Demonstrated experience leading design, analysis, interpretation, and reporting of clinical trials.
• Experience supporting regulatory interactions and major health authority submissions.
• Deep understanding of statistical methodology for clinical development, missing data, and adaptive methods.
• Strong knowledge of CDISC SDTM/ADaM standards; excellent SAS programming skills; R is a plus.
• Experience overseeing CROs, consultants, and external vendors.
• Proven ability to influence program strategy and cross-functional decision making.

Responsibilities

• Serve as senior biostatistics lead and SME for assigned studies and programs.
• Provide statistical leadership into program-level decision making, study design, and regulatory interactions.
• Collaborate with cross-functional teams to ensure statistics support objectives.
• Lead statistical design of trials including sample size, randomization, analyses, and missing data.
• Author or oversee statistical analysis plans and safety/effectiveness summaries.
• Ensure data collection, eCRF design, and analytics align with regulatory requirements.
• Develop table, listing, and figure shells; guide SDTM/ADaM datasets.
• Oversee CROs and vendors to ensure timely, high-quality outputs.
• Communicate results to leadership, external collaborators, and regulators.
• Contribute to study reports, DSURs, regulatory submissions, and publications.

Skills

Pharmacometrics?

Education

Ph.D. in Statistics

Master's in Statistics or Biostatistics

Tools

SAS

R

Job description

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.

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
• 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

MA Pay Range

$250,000 - $290,000 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.