Senior Director, Medical Affairs Biostatistics

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. 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. Location: Waltham, MA.

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; 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; Provide statistical expertise to HEOR, Value & Access, HTA, and payer-related activities; Provide statistical leadership for clinical outcomes assessment, including PRO/HRQoL analysis, psychometric evaluation, score derivation, and endpoint interpretation; Lead the statistical strategy for Medical Affairs publications and scientific communications; Partner with Clinical Development Biostatistics to ensure consistency across the product lifecycle; Analyze, interpret, and communicate complex results to cross-functional teams, senior leadership, external collaborators, and non-technical audiences; Develop, review, and execute analysis plans, statistical analysis plans, table/listing/figure shells, dataset specifications, and associated documentation; Partner with Data Management, Statistical Programming, Clinical Operations, and external vendors; Provide oversight of CROs, consultants, and external vendors; Drive standardization, process improvement, templates, best practices, and functional standards within Biostatistics; Manage, mentor, and develop direct reports and other statistical colleagues

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 communicate complex statistical concepts to technical and non-technical audiences, including senior leaders and external stakeholders

Nice to have

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