Senior Manager, Biostatistics

Kite Pharma•Foster City, CA

14d•$153,935 - $219,120

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows. Job Description As a Senior Manager, Biostatistics, at Kite Pharma 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, 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

PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 2+ years of relevant experience OR MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 6+ years of relevant experience OR BS/BA in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 8+ 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 scientific judgment and ability to interpret complex data clearly.
Strong communication and organizational skills.
Experience developing software and other tools to support statistical analysis of biomedical or related data.
Strong proficiencies in SAS and R.
Proven effectiveness managing projects.
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-study based, such as Biostatistics tools, programming, centralized analyses and reporting, etc.
Contributes to cross-functional clinical development planning for one or more studies; provide the biostatistical perspective and biostatistical input.
Contributes to gathering, organization and analysis of different data sources to enable delivery of 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.
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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