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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 is for a statistician to support the expanding anti-infectives portfolio, including next-generation Covid treatments. The statistician will be involved in the design, analysis, and reporting of clinical protocols covering early clinical development from first in human through proof of concept/phase 2b.

Role Responsibilities

• Collaborate with various scientists in the design, analysis and reporting of clinical studies (typically through Phase II).

• Core member of scientific teams responsible for determining strategy and delivering results in a timely and high-quality environment.

• Interact with internal and external experts to assure sound quantitative approaches are applied to collection and analysis of a wide variety of data types.

• Leader to bring 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.

• Interact with regulatory agencies regarding accelerated clinical development options for indications that have substantial unmet medical need.

• 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 assay methods are appropriately blinded, randomized 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.

• Provide high quality support for due diligence activities for in-licensing opportunities

• Comply with all statistics and quality processes and standards that are applicable to statistical outputs, and support processes that require statistical input

Basic Qualifications

• M.S. degree or PhD in Statistics (or related field) with at least 3 years’ relevant experience in applying statistics in a pharmaceutical or related industry.

• Experience applying statistical methods to the prospective design and analysis of scientific and/or clinical problems.

• Experience with modeling and simulation.

• Must be able to explain statistical techniques and considerations to non-statisticians.

• Capability to provide statistical leadership to cross-functional teams

• Demonstrated strong communication skills, both oral and written.

• Demonstrated ability to work effectively as a part of a team.

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Preferred Qualifications

• Strong computational skills in R or SAS or other statistical applied software systems.

• Prior experience providing statistical support to early phase clinical studies preferred.

• Experience in using or sound understanding of the value of Bayesian methods in scientific research preferred.

• Prior experience providing statistical support to clinical studies in anti-infectives is a plus.

Other Job Details

• Eligible for Employee Referral Award

• Eligible for Relocation Package (Only U.S. based candidates who qualify for a move to Cambridge, MA per policy guidelines)