Associate Director, Biostatistics (Biotech)

Location: Boston, United States; hybrid schedule with at least two on-site days per week, currently Tuesday and Wednesday

Salary: $181,000–$235,000 USD per year, plus potential discretionary annual bonus and long-term incentive award

Company

Clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Lead statistical activities for clinical studies from protocol design through clinical study reports.
• Develop statistical analysis plans, sample-size and power calculations, and randomization schemes.
• Oversee the production and quality control of tables, listings, and figures performed internally or by CRO partners.
• Collaborate with Clinical, Regulatory, and Data Management teams on study design, protocol development, and data review.
• Provide statistical input for regulatory submissions, briefing documents, health authority responses, reports, and publications.
• Ensure statistical deliverables meet ICH guidelines and applicable regulatory standards.

Requirements

• PhD in Biostatistics, Statistics, or a closely related quantitative discipline.
• Advanced proficiency in SAS and/or R.
• Strong knowledge of clinical trial design and operation, ICH E9 principles, and CDISC ADaM standards.
• Experience with adaptive trial designs, interim analyses, and Bayesian or frequentist methods.
• Experience overseeing CRO statistical deliverables, quality management, governance, and biostatistics standards.
• Ability to lead statistical strategy discussions and communicate complex statistical results to non-statistician, regulatory, and senior leadership audiences.

Nice to have

• At least five years of biostatistics experience in pharmaceutical, biotechnology, or CRO settings.
• Experience in immunology, inflammation, or a related therapeutic area.

Culture & Benefits

• Hybrid work arrangement with additional on-site attendance possible based on business needs.
• Health and wellness coverage tailored to the hiring country or region.
• Paid time off, public holidays, and additional leave in accordance with local requirements.
• Potential annual bonus and long-term incentive award based on individual and company performance.