Senior Director, Biostatistics

Responsibilities

• Provide strategic leadership for biostatistics across multiple development programs and therapeutic areas
• Establish and drive statistical strategy for clinical development programs
• Serve as the senior biostatistics representative on cross-functional governance and strategy committees
• Oversee statistical contributions to major regulatory interactions and submissions
• Influence clinical development through innovative trial designs and endpoint selection
• Partner with Clinical Development, Regulatory Affairs, and Data Sciences to support portfolio decision-making
• Drive statistical excellence and ensure application of industry best practices
• Provide strategic oversight of statistical analysis plans and study designs
• Manage relationships with external stakeholders and regulatory agencies
• Identify organizational risks and recommend solutions to enhance development success
• Influence enterprise-level decisions regarding portfolio prioritization and resource allocation

Requirements

• PhD in Statistics or Biostatistics
• At least 15 years of experience in pharmaceutical or biotechnology companies
• Solid statistical knowledge in clinical trial design (early to late phase)
• Proven track record of using statistical methods for clinical trial decision-making
• Experience authoring study SAP and TFL shells
• Extensive experience managing statistical vendors
• Proficiency in statistical computational languages such as SAS
• Working knowledge of regulatory guidance for clinical trials
• Strong organizational and project management skills
• Ability to communicate effectively in a work-from-home environment

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match
• Flexible time off
• Generous parental leave

About the Company

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders.