Sr Manager, Biostatistics

Kite Pharma•Foster City, CA

7d•$169,320 - $219,120

About The Position

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.

Requirements

PhD or PharmD
Strong knowledge of statistical principles and clinical trial methodology in the pharmaceutical or biotechnology industry.
Proficiency in statistical programming using SAS and R.
Strong communication and organizational skills, with the ability to explain quantitative findings, influence decision-making, and manage multiple priorities in a matrix environment.

Nice To Haves

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 programs is highly desirable.
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 communications.
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.
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 control arms, etc.).

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.
Represent Biostatistics in governance and development forums, ensuring scientific rigor, regulatory compliance, and reproducibility across programs.
Provide mentorship and technical guidance to junior team members and stay current with evolving regulatory guidance, statistical methodology, and advances in oncology and cell therapy.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem