Sr. Director, Biostatistics

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Job description

Sr. Director, Biostatistics
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Title: Sr. Director, Biostatistics

Location:

Position is office based in Foster City, CA or Parsippany, NJ or Seattle, WA

POSITION OVERVIEW:

You will lead and manage a team of direct reports responsible for all biostatistical activities across a large, complex portfolio of studies and other projects, which may span multiple disease areas, a whole therapeutic area, or another significant area within Biostatistics. You and your direct reports will collaborate with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans, and providing biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may manage or otherwise lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc. You will also be expected to lead short- and long-range Biostatistics strategies, plans and infrastructure development for the assigned area.

EXAMPLE RESPONSIBILITIES:

• Leads and manages a team of direct reports and may manage other people leaders. Hires, develops and retains diverse top talent in the team. Sets clear and elevating goals for the team and individual direct reports. Coaches team on their performance, development and career interests.
• Makes significant contributions to our abilities to hire, develop and retain diverse talent with impact in and outside own team.
• Oversees and directs all biostatistical activities for a large, complex portfolio of clinical studies that may span multiple disease areas, an entire therapeutic area, or a large, complex portfolio of other non-molecule projects.
• Where applicable, oversees and directs statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with own team, other Biostatistics team members and cross-functional partners. Ensures appropriate statistical consultation on trial design and study endpoints and timely and well-executed authoring of statistical analysis plans. Depending on area of assignment, may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc.
• Where applicable, oversees and contributes to completion of all technical and operational statistical activities for a portfolio of clinical trials. Directs internal and external teams in the definition, execution and completion of statistical activities for disease or therapeutic area products of considerable complexity.
• Where applicable, participates in or otherwise ensures appropriate biostatistical representation in cross-functional clinical development planning and clinical study protocol design and review discussions for disease or therapeutic area products.
• Where applicable, advises or otherwise ensures timely and appropriate advice to internal and external partners on statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
• Ensures timely and appropriate gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for therapeutic area products.
• As needed or otherwise appropriate, defines and oversees enhancements to statistical software or other biostatistical tools and techniques; maintains knowledge of current and emerging trends in statistical analysis methodologies and tools.
• Reviews and approves biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
• Typically takes a lead in special projects that can benefit multiple Biostatistics team members, such as new methodologies, processes, technology and other tools, and may also lead the development and / or implementation of SOPs and related documentation.
• Develops and cultivates relationships with external thought leaders and others who can influence our business and portfolio.
• Independently creates and manages resource plans for large Biostatistics teams and large-scale infrastructure development that brings value to multiple or all Biostatistics teams.
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs, and ensures the same across own team.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• MS or PhD in biostatistics or related discipline with 12+ years' relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry or a related environment.
• Multiple years' experience leading biostatistics or related strategies and teams for highly complex business areas and/or workstreams, including short- and long-range strategic planning, governance and oversight.
• Typically has extensive years' line management (direct reports) experience and a strong track record over successive years in hiring, managing and developing diverse top talent. Has made significant contributions to the talent pipeline and bench.
• Extensive biomedical statistical analysis experience and experience working with relevant software.
• Experience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools used typically used by Biostatistics.
• Demonstrated excellence leading large and complex teams.

Knowledge & Other Requirements

• Has an expert-level of knowledge of biostatistics and the latest trends and evolutions, as evidenced by proven track record in setting short- and long-range biostatistics strategies and plans.
• Has advanced knowledge of biostatistics best practices and tools and has shown ability to apply this to improve overall results.
• Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes.
• Has in-depth understanding of the cross-functional roles and responsibilities involved in drug development.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams . click apply for full job details
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