Manager, Biostatistics

Kite Pharma • Foster City, CA

9h • $133,195 - $189,640

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Manager, Biostatistics , at Gilead you will ... Support biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating 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 contribute to the projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc. You will also contribute to short- and long-range Biostatistics strategies, plans and infrastructure development that transcend multiple areas and teams across Biostatistics, such as team capability development.

Requirements

• 6+ Years of relevant experience with BS/BA in Biostatistics, Statistics, Mathematics, or a related quantitative discipline OR MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 4+ years of relevant experience

Nice To Haves

• PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 2+ years of relevant experience
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Has knowledge of biomedical statistical analysis, best practices and tools and has shown ability to apply this to improve overall results.
• Understands drug development phases and the nature of associated clinical trials across phases.
• Strong communication and organizational skills.
• 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.
• Proven effectiveness managing projects and teams.
• When needed, ability to travel.

Responsibilities

• Provides support to statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with other Biostatistics team members and cross-functional partners.
• Provides statistical consultation on trial design and study endpoints and authors 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.
• Contributes to cross-functional clinical development planning for one or more molecules or marketed products; provide the biostatistical perspective and biostatistical input.
• Contributes to 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 assigned products.
• Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for clinical development.
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager