Manager, Biostatistics

Pfizer   •  

Cambridge, MA

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 113 days ago

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 Oncology indications developed by Pfizer early Oncology research unit.  He/she will be involved in the design, analysis, and reporting of clinical protocols covering early clinical development from first in human through registration.   He/she will provide statistical expertise on regulatory submissions and ensure the quality and appropriateness of submission deliverables.

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.  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 Oncology indications developed by Pfizer early Oncology research unit.  He/she will be involved in the design, analysis, and reporting of clinical protocols covering early clinical development from first in human through registration.   He/she will provide statistical expertise on regulatory submissions and ensure the quality and appropriateness of submission deliverables.

ROLE RESPONSIBILITIES

  • 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. in Statistics or Biostatistics and a minimum of three years experience in applying statistics in a pharmaceutical or related industry or a Ph.D. in Statistics or Biostatistics.

Ideally, the candidate’s experience would include exposure to the design and analysis of clinical studies in both early and late stage clinical development.  The preferred candidate will have excellent statistical knowledge with the ability to apply this to scientific and clinical problems and experience with modeling and simulation in early clinical development and experience in using Bayesian methods to scientific research.

The preferred candidate will have strong computational skills in R, S-plus, or SAS and other statistical applied software systems such as Winbugs. Prior experience providing statistical support to clinical studies in oncology is a plus. Must be able to explain statistical techniques and considerations to non-statisticians. Good communication skills and the ability to work collaboratively with the clinical project team are required.

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