Associate Director, Biostatistics
Posted on Apr 5, 2021 by Pfizer
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. The statistician will support the development of innovative and efficient plans for developing new medicines in a variety of therapeutic areas. ECD supports early clinical development for inflammatory and autoimmune indications developed by Pfizer early Inflammation and Immunology research unit. She/he 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. He/she will provide statistical expertise on regulatory submissions and ensure the quality and appropriateness of submission deliverables.
Collaborate with various scientists in the design, analysis and reporting of early clinical studies.
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 to design more efficient studies where appropriate.
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.
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.
M.S. or PhD in Statistics or related disciplines as well as a minimum 3 years (5 years for M.S.) of experience of applying statistics in a pharmaceutical or related industry.
Experience applying statistical methods to the prospective design and analysis of scientific and/or clinical problems.
Pharmaceutical applications desired, with early clinical (phase I and phase II) and translational experience a definite advantage.
Prior experience providing statistical support to clinical studies in inflammation and immunology is a plus.
Experience in using or sound understanding of the value of Bayesian methods in scientific research is also a plus.
Experience running simulations and mixed models.
Experience with multivariate statistics and statistical methods to quantify uncertainty in multi-dimensional data.
Demonstrated strong communication skills, both oral and written.
Demonstrated ability to work effectively as a part of a team.
Technical Skills Required
Must have R or SAS programming skills.
Must be able to explain statistical techniques and considerations to non-statisticians
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