Director, Biostatistics - Clinical Drug Development
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.
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Job DescriptionDirector, Biostatistics - VirologyLocation
: Foster City, WA or
Seattle, WAPOSITION 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. 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.
- Oversees and directs all biostatistical activities for a large, complex portfolio of clinical studies that may span an entire disease 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 oversee and direct 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 disease or 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.
- Independently creates and manages resource plans for assigned area.
- Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs, and ensures the same across own team.
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
Knowledge & Other Requirements
- PhD in biostatistics or related discipline with 8+ years' relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry or a related environment.
- MS in biostatistics or related discipline with 10+ years' relevant experience in statistical analysis of biomedical data using SAS software.
- Minimum of 4 years' cross-functional project management or leadership experience in biostatistics or related field in the biopharma industry or a related environment, including multiple years' managing project teams.
- Typically has significant line management (direct reports) experience with proven effectiveness and success in hiring, managing and developing diverse top talent.
- 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 in complex project management and effectively managing multiple projects and priorities.
- Has an expert-level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for a large, complex portfolio of projects.
- 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, executives and steering committees.
- When needed, ability to travel.
The salary range for this position is: $214,795.00 - $277,970.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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