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Senior Vice President, Biostatistics and Analytics

2 months ago

South San Francisco, California, United States Annexon Bioscience Full time
About the Role

We are seeking a highly experienced and accomplished Executive Director, Biometrics and Data Science to lead our Biometrics team at Annexon Biosciences. As a key member of our leadership team, you will be responsible for providing strategic direction and operational oversight for all aspects of biostatistics, statistical programming, modeling and simulation, and advanced analytics within our organization.

Key Responsibilities
  • Strategic Leadership: Develop and execute the overall biometrics strategy in alignment with corporate goals and objectives, providing leadership and guidance to the Biometrics team, fostering a culture of innovation, collaboration, and excellence.
  • Clinical Trial Support: Oversee the design, planning, and implementation of statistical methodologies for clinical trials, ensuring accuracy and compliance with regulatory requirements, collaborating with cross-functional teams to develop and review study protocols, statistical analysis plans, and data collection processes.
  • Statistical Analysis and Reporting: Lead the statistical analysis and interpretation of clinical trial data, including efficacy and safety outcomes, preparing and reviewing statistical reports, summaries, and regulatory submissions for investigational and marketing applications.
  • Regulatory Compliance: Ensure compliance with regulatory guidelines, standards, and industry best practices related to biometrics activities, representing the company in interactions with regulatory agencies and supporting regulatory submissions as needed.
  • Team Development: Recruit, mentor, and develop a high-performing team of biometrics professionals, providing training, guidance, and support to enhance individual and team capabilities.
Requirements
  • Advanced degree (Ph.D. or M.S.) in biostatistics, statistics, or a related field.
  • Extensive experience - at least 10 years in biometrics roles within the biopharmaceutical industry, including leadership positions.
  • In-depth knowledge of statistical methodologies, clinical trial design, and regulatory requirements (e.g., FDA, EMA).
  • Strong understanding of data management principles, tools, and technologies.
  • Excellent leadership, communication, and interpersonal skills.
  • Proven ability to effectively manage multiple projects and priorities in a fast-paced environment.
  • Demonstrated strategic thinking and problem-solving abilities.
  • Experience with adaptive trial designs and complex statistical modeling techniques, including proportional odds, Bayesian analyses, and real-world evidence studies.
  • Familiarity with software platforms commonly used in biometrics (e.g., SAS, R).
  • Track record of successful regulatory submissions and interactions.
  • Ability to travel.
About Annexon Biosciences

Annexon Biosciences is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and our therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative, and ophthalmic diseases.