Senior Director, Biostatistics

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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