Director of Biostatistics

Key Responsibilities

• Serve as the statistical lead across one or more clinical development programs.
• Provide input into protocol design, statistical methodologies, analysis plans, and study execution.
• Author and review key statistical documents, including SAPs and regulatory submission deliverables.
• Lead statistical analyses and interpretation of clinical trial data.
• Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, Safety, and Medical Writing teams.
• Support regulatory interactions and submission activities.
• Oversee CROs and external statistical programming vendors.
• Ensure compliance with industry standards, regulatory guidance, and data quality requirements.
• Contribute to statistical standards, processes, and best practices across the organization.
• Mentor team members and provide technical leadership within Biometrics.

Qualifications

• PhD or Master's degree in Biostatistics, Statistics, or a related quantitative discipline.
• 10+ years of biotechnology and/or pharmaceutical industry experience in clinical biostatistics.
• Demonstrated experience leading statistical strategy from study design through regulatory submission.
• Strong knowledge of FDA, EMA, ICH, and CDISC requirements.
• Experience supporting regulatory submissions and health authority interactions.
• Prior experience within a clinical-stage biotech environment is strongly preferred.
• Preferred background includes experience supporting rare disease, immunology, or other specialized therapeutic areas.
• Familiarity with innovative clinical trial designs, small patient populations, or complex development programs.
• Ability to balance strategic leadership with hands-on execution.