Manager, Biostatistics, Early Clinical Development

ROLE SUMMARY

Biostatisticians play a critical role in the advancement of new medicines at Pfizer. The right candidate will partner with clinicians, clinical pharmacologists, translational medicine, and other scientists to support drug development in Pfizer's Early Clinical Development (ECD) unit. This role will provide statistical support in the early development of new anti-cancer programs. He/she will be involved in study design, clinical protocol development, data analysis, and study outcome reporting, etc. The position will be accountable for the robust planning and execution of oncology clinical development programs.

ROLE RESPONSIBILITIES

• Collaborate with various cross-functional scientists in the design, analysis and reporting of early oncology clinical studies (typically through Phase II).
• Author statistical analysis plan for early oncology programs and provide statistical guidance to statistical programming group.
• Participate in scientific teams responsible for determining strategy and delivering results in a timely and high-quality environment.
• Interact withinternal and external experts to assure sound quantitative approaches are applied to collection and analysis of a wide variety of data types.
• Contribute to innovative statistical thinking and methods to help drive the enhanced quantitative drug discovery and development paradigm within Pfizer. Central to this approach is the systematic review of prior information, statistical model building and simulation, utilizing Bayesian methods as appropriate, to design more effective studies.
• Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and designed to meet clear objectives.
• Use statistical expertise to influence both internal and external reports and presentations, with the aim to improve the quality of internal decision making and increase our influence on the external environment.

QUALIFICATIONS

• MS in statistics or biostatistics with a minimum of 3 years' pharma experience, or a Ph.D. in statistics or biostatistics
• Excellent statistical knowledge and experience with modelling and simulation in clinical trials and expertise in using Bayesian methods
• Demonstrated competency with the design, implementation, analysis and reporting of clinical trials
• Strong computational skills in R, SAS and other statistical software systems
• Prior experience in oncology clinical trials is a plus
• Good communication skills and the ability to work collaboratively with the clinical project team

Relocation support available
Work Location Assignment:Flexible

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Relocation assistance may be available based on business needs and/or eligibility.

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Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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