Director, Biostatistics

Our Waltham-based biotech client is seeking an experienced Director of Biostatistics to provide strategic and hands-on statistical leadership across clinical development programs. This individual will play a key role in study design, data analysis, regulatory support, and cross-functional collaboration, helping advance innovative therapies through clinical development.

Responsibilities

• Lead statistical strategy and provide biostatistical support across clinical studies.
• Design, analyze, and interpret clinical trial data to support development decisions.
• Develop study designs, statistical methodologies, and analysis plans.
• Author and review Statistical Analysis Plans (SAPs), statistical outputs, and clinical study reports.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and external partners.
• Provide oversight of external CROs, biostatistics vendors, and programming activities.
• Support regulatory submissions and health authority interactions as needed.
• Generate clear and impactful presentations, visualizations, and statistical summaries for internal and external stakeholders.
• Contribute to the integration and interpretation of clinical, safety, and biomarker data.

Requirements

• PhD in Biostatistics, Statistics, or a related quantitative discipline with significant industry experience, or Master's degree with equivalent experience.
• Demonstrated experience supporting clinical development programs within biotechnology or pharmaceutical organizations.
• Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
• Experience developing SAPs and supporting clinical studies through key development milestones.
• Proficiency with R, SAS, or other statistical programming tools.
• Excellent communication skills with the ability to translate complex statistical concepts for technical and non-technical audiences.
• Experience working in a collaborative, fast-paced environment.

Benefits

• Medical, dental, vision, life, and disability insurance plans.
• Employee Stock Purchase Program (ESPP).
• 401K program with company match after 12 months of tenure.
• Health Savings Account (HSA) on the HDHP plan.
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions.
• Corporate discount savings program and other discounts.
• On-demand training program and access to certification prep, technical and leadership courses/books/seminars after 6+ months of tenure.
• Certification discounts and perks for associations including CompTIA and IIBA.
• Dedicated customer service team and certified Career Coach.