Sr Manager, Biostatistics
- Compensation
- Not disclosed
- Location
- United States - California - Foster City
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- Not specified
- Category
- Not specified
- Posted
Skills
Must have
- PhD or PharmD
Nice to have
- Experience in hematology, oncology, immuno-oncology, cell therapy, gene therapy, or other advanced therapeutic modalities. Prior experience supporting CAR T-cell therapy or other immune-cell therapy p
- Knowledge of real-world data sources, registries, claims data, electronic health records, external control arms, or long-term follow-up evidence generation, including support of related scientific com
- Experience supporting regulatory submissions, health authority interactions, advisory committee preparation, or post-marketing commitments.
- Familiarity with advanced statistical methods such as Bayesian approaches, causal inference, adaptive designs, propensity score methods, multiple imputation and survival modeling etc.
- Ability to translate complex statistical analyses into clear business, clinical, regulatory, and scientific insights.
- Strong knowledge of statistical principles and clinical trial methodology in the pharmaceutical or biotechnology industry.
- Experience supporting clinical studies, external control arm and natural history studies from protocol development through analysis, reporting, and regulatory documentation.
- Solid understanding of oncology clinical development and hands-on experience on analyzing clinical trial data and real world data (including claims data, electronic health records, and external contro
- Strong communication and organizational skills, with the ability to explain quantitative findings, influence decision-making, and manage multiple priorities in a matrix environment.
Full description
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.
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Job Description
We are seeking a highly motivated Senior Manager, Biostatistics, to provide statistical support and strategic input across clinical development, medical affairs, safety, and real-world evidence generation activities in support of Kite’s cell therapy portfolio.
The successful candidate will serve as a key statistical partner on cross-functional teams, contributing to the design, execution, analysis, interpretation, and communication of clinical and post-marketing studies in hematologic malignancies, solid tumors, and next-generation cell therapy programs. This role requires strong technical expertise in biostatistics, a collaborative mindset, and the ability to apply innovative statistical thinking to complex clinical and real-world data in a rapidly evolving oncology and cell therapy environment.
The Senior Manager will work closely with colleagues in Real-World Evidence, Statistical Programming, Clinical Operations, and Data Management, to support Clinical Development, Medical Affairs, Safety, Regulatory Affairs, Translational Medicine, and other functions to generate high-quality evidence that supports development strategy, regulatory submissions, scientific communication, and patient-centered decision-making.
Key Responsibilities
- Provide statistical leadership for clinical trials and related evidence-generation activities across Kite’s cell therapy programs, including CAR T and next-generation cellular therapies.
- Lead study design and analysis activities, including protocol development, endpoint selection, sample size determination, statistical analysis plans, interim analyses, ad hoc analyses and interpretation of results.
- Provide statistical support for regulatory submissions, health authority interactions, clinical study reports, and other key development documents.
- Contribute to scientific communications through publications, congress presentations, post-hoc analyses, and evidence-generation initiatives.