Biostatisticians play a critical role in the advancement of new medicines at Pfizer. The right candidate will partner with senior management, clinicians, clinical pharmacologists, translational medicine, and other scientists to support early clinical development for Oncology. The statistician will be involved in the design, execution, analysis, and reporting phases of clinical protocols and provide statistical expertise on regulatory submissions and ensure the quality and appropriateness of submission deliverables. She/he will support the development of innovative and efficient plans for developing new medicines in a variety of cancer indications. She/he will review scientific literature, promote innovation, efficient design and quantitative decision-making within research and in partnership with other lines, reducing the time and cost of drug development.
Collaborate with various scientists in the design, analysis and reporting of laboratory and early 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.
Frequently 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.
Qualifications
The qualified candidate must have a M.S. or Ph.D. in Statistics, Biostatistics, or related field, as well as a minimum of 6 years experience in applying statistics in a pharmaceutical or related industry. Ideally, this experience would include exposure to the design and analysis of clinical studies in oncology early clinical development. The preferred candidate will have excellent statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, and Bayesian statistics. The preferred candidate will have a proven ability to manage multiple complex projects with a track record of influencing external environment through contributions to scholarship, working parties etc., as evidenced by committee membership, presentations and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical methodologies.
Strong communication skills with the ability to influence widely and work collaboratively with clinical project teams and senior management are required.
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