Manager, Biostatistics

Manager, Biostatistics

United States – Maryland – Frederick, United States – California – Foster City Clinical Development & Clinical Operations Regular

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.

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.

• 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; provides 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.

• 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

• PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 2+ years of relevant experience
• Demonstrated…