VP, Clinical Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic direction and operational supervision for the design, analysis, and reporting of clinical trials throughout all development phases.

• Ensure top-notch statistical and data management support for clinical programs.

• Propel clinical programs toward effective trial design and execution, regulatory submissions, and successful commercialization.

• Build and manage a high-performing clinical biostatistics team utilizing both internal and external resources.

• Recruit, hire, mentor, and oversee biostatisticians, programmers, and external vendors.

• Develop and execute a biostatistics and data management strategy for the clinical development pipeline.

• Provide expert advice on statistical methodologies, study design, and data analysis.

• Contribute to clinical development plans and strategies for regulatory submissions.

• Oversee statistical analysis plans, clinical trial protocols, and essential documentation.

• Ensure data management processes align with industry standards and regulatory requirements.

• Collaborate with clinical development, regulatory, medical affairs, vendors, and regulatory bodies.

• Represent the company in discussions with global regulatory agencies.

• Prepare and review submission documents while providing statistical insights for regulatory responses.

• Foster the adoption of innovative methods, technologies, and best practices.

⛳️ Requirements

• Ph.D. or Master’s degree in Biostatistics, Statistics, or a related discipline.

• Over 10 years of experience in clinical biostatistics, with substantial exposure to small molecule drug development.

• Demonstrated success in leading and building clinical biostatistics teams, ideally in a biotech or pharmaceutical environment.

• Expertise and experience across various therapeutic areas.

• Extensive knowledge of regulatory standards (FDA, EMA, ICH) and experience with regulatory submissions.

• Strong programming capabilities in SAS, R, or similar statistical software.

• Familiarity with EDC systems.

• Exceptional leadership, communication, and collaboration abilities.

• Capacity to work effectively across different functions and levels.

• Strategic mindset, hands-on approach, and enthusiasm for innovation.

🏝️ Benefits

• Medical, dental, and vision insurance covered at 90%.

• 401(k) plan with company match.

• Flexible Paid Time Off (PTO).

• A company-wide weeklong recharge break.

• Adoption assistance.