Senior Director, Biostatistics - Oncology Programs

Senior Director, Biostatistics - Oncology Programs
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 #CreatingPossible

Position Overview:

Reporting to the Head of Oncology Biostatistics, the Senior Director of Biostatistics will lead, manage and develop a group of statisticians that support oncology late development, providing statistical leadership and oversight to the development plans, regulatory interactions, and HTA/commercial evaluation of a Gilead oncology compound in one or more indications. The ideal candidate needs to have a proven track record of functional leadership, mastery of statistics in drug development, as well as excellence in people management and development.

Key Responsibilities:

• Statistical leadership to late-stage oncology clinical trials: developing trial design options and providing high quality decision support
• Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head
• Works collaboratively with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
• Uses knowledge of Regulatory requirements regarding statistical principles to ensure the company meets its Regulatory, scientific, and business objectives; collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company, negotiates project timelines given constraints, works with senior management and Human Resources to identify long-term staffing plans, provides career development opportunities to staff, and participates in strategic risk assessment based on statistical analyses or principles

Education and Experience:

• 10+ year of industry experience in the statistical analysis of biomedical data using statistical software and a PhD degree in Biostatistics or equivalent
• Extensive hands-on experience in oncology drug development including design and analysis of phase 3 oncology trials and active participation in NDA/BLA filing through label negotiation
• Good understanding of the business beyond the area of Biostatistics and is a recognized authority outside of the company
• Demonstrated effective verbal and written communication skills and interpersonal skills
• Makes effective decisions with limited information
• Has strong networks developed that influence collaborations with external academic or government organizations to extend visibility or business need of the company
• Effectively uses competitive intelligence to influence clinical development strategies
• Proven ability to lead, mentor and develop a team of experienced statisticians
• Proven effective interpersonal skills to create collaborative relationships within the function as well as with all cross functional organizations

For jobs in the United States:
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 careers@gilead.com 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.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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