Director, Biostatistics
$206,000–$257,500 year
Hybrid · Cambridge, Massachusetts, United States
Job Summary
Lead collaboration with internal and external teams to coordinate planning and execution of statistical deliverables for Duchenne muscular dystrophy (DMD) and siRNA programs. Conduct statistical modeling to enable robust design, review CRF designs, author/review analysis plans and statistical sections of clinical trial documents, provide input to DMC/IRB charters, oversee CRO statistical services, mentor junior statisticians, and apply modern analytical tools (SAS, R, Python) to generate rapid insights while ensuring traceability and regulatory readiness. Hybrid work on site in the United States with potential in-person events; target salary range $206,000–$257,500 per year.
Required Qualifications
- PhD strongly preferred with 9+ years in statistics or related discipline in pharmaceutical/biotech
- Master’s degree with 10+ years in statistics or related discipline
- Demonstrated ability in design, analysis, and reporting of clinical trials
- Experience with regulatory submissions (NDAs/MAAs) preferred
- Proficiency in SAS and R; Python and other languages a plus
- Experience with SDTM and ADaM data standards
- Ability to lead statistical efforts across multiple studies and mentor junior biostatisticians
- Excellent written and oral communication skills; ability to communicate statistical concepts clearly
- Willingness to perform hands-on data exploration using R and/or Python alongside SAS
- Knowledge of FDA, EMA, ICH regulations and guidelines
- Experience with external controls, real-world evidence, or observational study methods a plus
- Strong collaboration with Clinical, Medical, Regulatory teams to shape analytical strategy
- Proficiency with statistical design software such as EAST
- Ability to work in a hybrid on-site US setting
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