Senior Director, Medical Affairs Biostatistics

Dyne Therapeutics•Waltham, MA

13d•Onsite

About The Position

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.

Requirements

PhD in Statistics, Biostatistics, or a related quantitative discipline with 10+ years of relevant pharmaceutical, biotechnology, or health-related industry experience; or MS with 12+ years of relevant experience.
Demonstrated experience leading the design, analysis, interpretation, and reporting of analyses within Medical Affairs, including Phase IV, observational, registry, and real-world evidence studies.
Experience supporting scientific publications, congress presentations, investigator-sponsored research, and external scientific engagement, including collaboration with investigators and presentation of statistical findings.
Strong expertise in statistical methodology relevant to observational and real-world research, including study design, bias and confounding, causal inference, longitudinal analysis, missing data, endpoint strategy, and time-to-event methods.
Advanced SAS programming skills are required.
Ability to perform, review, and oversee statistical analyses.
Experience overseeing CROs, consultants, and external vendors, including scope 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.

Nice To Haves

Experience in rare disease drug development, preferably neuromuscular disease.
Familiarity with R and contemporary tools and approaches for real-world data analysis are preferred.
Interest in and basic understanding of biology and biological processes, including ASO and siRNA modalities.

Responsibilities

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.
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.
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.
Develop, review, and execute analysis plans, supplemental statistical analysis plans, table/listing/figure shells, dataset specifications, and associated documentation to ensure high-quality, inspection-ready statistical deliverables.
Partner closely with Data Management, Statistical Programming, Clinical Operations, and external vendors to ensure fit-for-purpose data, efficient study execution, and high-quality, timely statistical deliverables supporting Medical Affairs studies and evidence-generation initiatives.
Provide oversight of CROs, consultants, and external vendors, including scope, quality, timelines, resourcing, issue escalation, and delivery of statistical services.
Drive standardization, process improvement, templates, best practices, and functional standards within Biostatistics and across cross-functional teams.
Manage, mentor, and develop direct reports and other statistical colleagues through direct management, matrix leadership, and technical mentorship, fostering technical excellence, collaboration, accountability, and a high-performing team environment.