Senior Director, Biostatistics
$250,000–$290,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Lead statistical strategy and execution for assigned clinical studies, programs, and development initiatives across the drug development lifecycle. Provide statistical leadership for protocol development, analysis plan authoring, and oversight of statistical analyses and deliverables. Partner with cross-functional stakeholders to ensure statistical strategies support program objectives and lead the design of clinical trials, including sample size determination and analytical approaches. Author, review, or oversee statistical analysis plans, integrated summaries, and clinical study reports. Provide oversight of CROs, consultants, and external vendors to ensure high-quality delivery. Interpret and communicate clinical trial results to cross-functional teams, senior leadership, and regulatory agencies. Lead statistical strategy for global regulatory submissions and prepare for health authority interactions. Manage, mentor, and develop direct reports while fostering a high-performing team environment.
Required Qualifications
- Ph.D. (or Masters) in Statistics, Biostatistics, or a related quantitative discipline
- 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
- 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
Desired Qualifications
- Experience in rare disease drug development
- Experience with R
- Experience in rare disease or neuromuscular disease
- Interest in and basic understanding of biology and biological process including ASO and siRNA
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