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. Gileads 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 companys five core values. Thats 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 #CreatingPossible
VP, Head of Biostatistics
Reporting to the SVP of Data Sciences and Biometrics, the Head of Biostatistics will lead the Biostatistics function within and across therapeutic areas. This individual will oversee all biostatistics workstreams for clinical trials, assets evaluations, and regulatory submissions.
Through this individual's leadership, the Biostatistics function will collaborate with cross-functional groups broadly across the organization and provide statistical input into clinical development strategies, study designs and the analyses that drive Gilead's pipeline. This role is an influential leader within the company, championing appropriate statistical approaches for the design and analysis of clinical studies and interpretation of data and driving the institution of best practices with regard to biostatistics' role in the planning, execution, and interpretation of clinical projects and studies.
As the Head of Biostatistics, this individual will also be the executive sponsor for the statistical innovation center at Gilead. Innovation in statistics drives innovation in clinical development plans and clinical trial designs. The increased use of synthetic patients/control arms, adaptive designs, platform trials, quantitative decision-making, prediction modelling are all approaches which are yielding significant efficiencies, when applied. The emerging field of Data Science has also demonstrated early indications of business value in the biopharmaceutical industry. The VP Biostatistics will steer the innovation strategy, establish strategic collaborations with external organizations, and drive the rigorous development of novel statistical and data sciences methodologies.
The ideal candidate will have a proven track record of functional leadership, strategic situational judgement in using both innovative and pragmatic statistics, as well as demonstrated motivation for and excellence in people management and development.
- Strategic Thinking: Aligns with Clinical Development senior leadership to define and implement a technically advanced cross functional biostatistics strategy; Maintains a broad understanding of relevant external global trends, anticipating emerging issues relevant to the department, identifying strategic needs in technical knowledge and setting the strategic direction for the department to meet regulatory, scientific and business needs.
- Innovation: Uses statistical modelling to collaborate with Clinical Development, Epidemiology, Therapeutic Area Heads, Regulatory and other functional teams to identify and deliver new solutions for addressing Gilead's needs; Keeps up to date on cutting edge analytical approaches by actively participating in technical meetings and maintaining relationships with external innovators to constantly bring the best solutions to Gilead
- Delivery Excellence: Builds and develops an expert team of statisticians in advanced analytic techniques to support goals across therapeutic areas; Leads an assessment of Gilead's current statistics capabilities and strengths and develops a roadmap for building additional capabilities where needed; Ensures the execution and statistical integrity of protocols, statistical analysis plans, study reports and presentations and publications of clinical studies by applying your past experiences and providing statistical leadership
- Influence and Partnership: Enables data-driven decision making within Gilead Clinical Development to increase the impact of existing programs; Creates external relationships with academic and industry experts in order to stay abreast of emerging technologies; Identifies, selects and develops partners, including vendors and collaborators (both academic and industry), ensuring alignment with the overall vision of R&D and identifying cross functional benefits
- People Development: Develops others by identifying and mentoring high performers and building a culture of inclusion and collaboration throughout the organization; Delegates responsibility and empowers others.
- Decision-making: Maintains a culture of rigorous data-driven decision making that rewards truth-seeking behavior; Encourages employees to exercise good judgement and embrace decision making; Empowers capable individuals to be accountable decision-makers
- Communication: Champions the Biostatistics function across all areas of the business; Creates excitement and passion for the role of Biostatistics to inform decisions across the organization
Capabilities & Requirements:
- Oversees the statistical support for the development of all compounds across therapeutic areas in close collaboration with Clinical Development, Regulatory Affairs, Global Drug Safety, Clinical Pharmacology, and Translational Development partners
- Advises and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impact
- Provides leadership, guidance and management to statisticians across therapeutic areas to ensure high quality and timely deliverables
- Manages Biostatistics resources and budgeting across therapeutic areas, sets priorities, and ensures consistency and adherence to standards therein
- Champions the creation/maintenance of training on statistical topics and departmental SOPs, Policies and Business Enablement Documents
- Represents the company in interfaces with regulatory agencies globally
- Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations and defenses
- Represents Gilead at professional societies, and in industry-wide technical discussions
- Identifies external statistical experts for consultation. Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities
- Participates in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests
- Interacts and manages KOLs/CROs and represents the company in external scientific forums.
- Provides guidance to employees' development plans and carries out performance review and feedback
- Provides active coaching to biostatistical team members when developing solutions to problems
- Builds a professional and effective Statistical community that is seen as a business asset, strategic partner and attracts, develops and retains top talent
Education & Qualifications:
- PhD in Biostatistics, Statistics or related field
- 15+ years of experience working in a Biotech/Pharma R&D business function
- Leadership and build experience across a global Biostatistics function in a pharmaceutical environment
- Demonstrated skill in the planning, analysis and reporting of clinical trials
- Detailed knowledge of statistical methodologies and statistical regulatory requirements
- In-depth knowledge of all clinical phases of the global drug development process
- Demonstrated ability to work in a team environment with clinical team members
- Demonstrated skill in resource planning and management
- Demonstrated ability to create and fulfill a vision in a matrix environment and work collaboratively with internal stakeholders across different functions
- Excellent oral and written communication skills, including the ability to translate between business leaders, scientists and technologists
- You are a natural leader and specialist in Biostatistics & Clinical Development who can bring teams closer together and architect the common use of statistical methodology in a variety of therapeutics areas
- You can create excitement and passion for the role of Biostatistics across the organization
- You are a reputable expert in building biostatistics functions who enjoys debating in biostatistics and novel methodologies, is persuasive and trusted by senior leadership teams
- You have strong interpersonal skills who is able to create collaborative relationships companywide and support individuals with their specific needs and help them understand the value of applying data science to their data
- You are a champion of the long-term vision for Biostatistics and its partnership with Epidemiology, Data Sciences, Bioinformatics and other analytics disciplines within Gilead
Gilead Core Values
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
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