Head of Biostatistics

1 week ago


Foster City, California, United States Gilead Sciences, Inc. Full time
Senior Director of Biostatistical Operations

At Gilead Sciences, we are dedicated to fostering a healthier world for everyone. For over 35 years, we have addressed significant health challenges, including HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of innovative therapies aims to enhance lives and ensure global access to these vital treatments. Our mission demands collaboration, determination, and an unwavering commitment to making a meaningful impact.

Every member of our team is essential in the discovery and development of transformative scientific advancements. Our workforce is our most valuable asset as we strive to realize our ambitious goals, and we seek passionate and driven individuals ready to make a tangible difference.

We believe that every employee deserves exceptional leadership. As a People Leader, you are pivotal in shaping our culture and creating an environment where every team member feels valued, developed, and empowered to achieve their goals. Join Gilead and help us create possibilities together.

Position Overview

In this role, you will oversee and guide a team responsible for all biostatistical functions across a diverse and intricate portfolio of studies and projects, which may encompass various disease areas or significant therapeutic domains. You and your team will collaborate with cross-functional partners to achieve clinical development project objectives and timelines. Responsibilities include providing statistical consultation on clinical development strategies, trial design, and study endpoints, as well as authoring statistical analysis plans and contributing biostatistical insights into clinical documentation, scientific publications, and regulatory submissions.

Key Responsibilities:

  • Lead and manage a team of direct reports, including other people leaders. Attract, develop, and retain diverse top talent within the team. Establish clear and ambitious goals for the team and individual members, while mentoring them on performance and career aspirations.
  • Significantly contribute to the hiring, development, and retention of diverse talent within and beyond your team.
  • Oversee all biostatistical activities for a large and complex portfolio of clinical studies, which may span multiple disease areas or a comprehensive therapeutic domain.
  • Ensure appropriate statistical consultation on trial design and study endpoints, and oversee the timely authoring of statistical analysis plans for NDA submissions.
  • Direct the completion of all technical and operational statistical activities for a portfolio of clinical trials, guiding internal and external teams in executing statistical tasks for complex disease or therapeutic area products.
  • Participate in cross-functional clinical development planning and protocol design discussions, ensuring adequate biostatistical representation.
  • Provide timely advice to internal and external partners on statistical analysis strategies and the interpretation of statistical results.
  • Organize and analyze various data sources to facilitate special projects and the delivery of statistical analysis plans.
  • Define and oversee enhancements to statistical software and biostatistical tools, staying informed on current trends in statistical methodologies.
  • Review and approve biostatistical contributions to clinical documentation, scientific publications, and regulatory submissions.
  • Lead special projects that benefit multiple team members, including the development of new methodologies and processes.
  • Build and maintain relationships with external thought leaders and stakeholders who can influence our business and portfolio.
  • Manage resource plans for large biostatistics teams and infrastructure development that adds value across teams.
  • Ensure adherence to regulatory standards, statistical principles, and Gilead SOPs across your team.

Qualifications:

We recognize that our differences enhance our ability to serve patients. Below are the qualifications and skills we seek for this role:

Minimum Education & Experience:

  • MS or PhD in biostatistics or a related field with over 12 years of relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry.
  • Extensive experience leading biostatistics strategies and teams for complex business areas, including strategic planning and oversight.
  • Proven track record in managing and developing diverse talent, contributing significantly to the talent pipeline.
  • In-depth experience in biomedical statistical analysis and familiarity with relevant software.
  • Experience in developing software and tools to support statistical analysis of biomedical data.
  • Demonstrated excellence in leading large and complex teams.

Knowledge & Other Requirements:

  • Expert-level knowledge of biostatistics and the latest trends, with a proven ability to set effective strategies.
  • Advanced understanding of biostatistics best practices and tools, with a focus on improving outcomes.
  • Strategic thinker capable of advising on statistical requirements to enhance project results.
  • Comprehensive understanding of cross-functional roles in drug development.
  • Familiarity with FDA and EMA regulations, ICH guidelines, and GCP.
  • Strong communication and organizational skills, with the ability to convey complex information clearly to various stakeholders.
  • Willingness to travel as needed.

The compensation for this position will be determined based on various factors, including experience and qualifications. This role may also be eligible for a discretionary annual bonus and stock-based long-term incentives, along with a comprehensive benefits package.

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions will be made without discrimination based on any protected characteristics.



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