Sr Manager, Biostatistics

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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.

We are seeking a highly motivatedSenior Manager Biostatisticsto provide statistical support and strategic input across clinical development medical affairs safety and real-world evidence generation activities in support of Kites 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 Kites 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.

Basic Qualifications

• PhD or PharmD

Preferred Qualifications

• 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.

• 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 control arms etc.). 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.

People Leader Accountabilities:

• 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

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

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