Manager, Biostatistics

Gilead Sciences•Foster City, CA

1d•$146,540 - $189,640•Onsite

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.

Requirements

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

Nice To Haves

PhD in Biostatistics, Statistics, or a related quantitative discipline, with 2+ years of relevant experience.
Strong knowledge of clinical trial design, drug development and regulatory principles, and exploratory analyses supporting publication in immuno-oncology.
Demonstrated expertise in statistical methodologies, with a solid understanding of industry practices in drug development. Knowledge related to pharmacokinetics/pharmacodynamics is a plus but not required.
Ability to work independently and collaborate effectively with cross-functional teams.
Excellent verbal, written, and presentation skills, including the ability to explain advanced statistical methods clearly and interpret results effectively.
Experience developing tools or AI agents to support statistical analysis or workflows is a plus.
Strong proficiency in SAS and/or R.

Responsibilities

Provide statistical guidance and support for drug development programs, including the design of translational development plans, studies, and analyses requiring advanced methodologies.
Develop and review translational statistical analysis plans (TSAPs), including derived variable definitions, analysis dataset structure, statistical methods, and templates for tables, figures, and listings for pharmacokinetics/pharmacodynamics (PK/PD) reports; author technical reports and publications; and ensure timely delivery of study results.
Provide statistical input and support to marketing applications (NDA/BLA) submitted to the FDA, EMA, and other global regulatory agencies.
Collaborate closely with scientists and clinicians to design and execute analyses for a range of clinical trial endpoints including translational and exploratory endpoints.
Advise research and translational teams on statistical, machine learning, and bioinformatics methodologies, including program and study design, clinical and biomarker data analysis, and multivariable predictive modeling.
Establish and maintain effective working relationships with external vendors and cross-functional project teams.
Monitor project progress, ensure appropriate resource allocation, oversee vendors for assigned programs, and provide quality review of vendor deliverables.