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Pfizer Inc.
Massachusetts, United States
23 days ago
Pfizer Inc.
Massachusetts, United States
23 days ago

Description

Why Patients Need You
Pfizer's Worldwide Medical and Safety colleagues play a key role in connecting evidence based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

ROLE SUMMARY

Biostatisticians play a critical role in the advancement of new medicines at Pfizer. The Director of Biostatistics will provide statistical leadership into one or more of the internal medicine research projects covering areas such as diabetes, obesity, NASH, cachexia or heart failure. This will involve strategic leadership and oversight of the clinical development planning and execution from first in human through to proof of concept/phase 2b. The statistician will thus support the development of innovative and efficient plans for developing new medicines in a variety of therapeutic areas. The right candidate will partner with clinicians, clinical pharmacologists, translational medicine, and other scientists in Pfizer's Early Clinical Development (ECD) unit to achieve this.

ROLE RESPONSIBILITIES

  • Collaborate with various cross-functional scientists in the design, analysis and reporting of laboratory and early clinical studies (typically through to the end of Phase 2)
  • Provide statistical leadership in one or more therapeutic areas including: diabetes; obesity; NASH; cachexia; and heart failure
  • 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 Model Informed Drug 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 and engage 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
  • Mentor and train junior level staff with potential to manage

BASIC QUALIFICATIONS

  • MSc degree in Statistics, Biostatistics, or related field
  • Minimum of 8 years' experience applying statistical methods in the pharmaceutical industry, with early clinical (Phase I and Phase II) experience a definite advantage
  • Experience in effectively applying statistical methods to the prospective design and analysis of scientific and/or clinical problems.
  • Experience with modelling and simulation in early clinical development and expertise in Model Informed Drug Development (MIDD) principles
  • Demonstrated strong communication skills, both oral and written
  • Demonstrated ability to work effectively as part of a team and proactively influence teams with innovative clinical development strategy
  • Demonstrated 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 (with experience in the creation of R SHINY Apps) or SAS or other statistical applied software systems.
  • Prior experience providing statistical support to early phase clinical studies preferred and in the internal medicine space a plus.
  • Experience in using or sound understanding of the value of Bayesian methods in scientific research preferred.


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.

OTHER JOB DETAILS

  • Eligible for Relocation Package (Only U.S. based candidates relocating to Cambridge, MA)
  • Eligible for Employee Referral Award



Job Information

  • Job ID: 63143795
  • Location:
    Massachusetts, United States
  • Position Title: Director, Biostatistics
  • Company Name For Job: Pfizer Inc.
  • Job Function: Biostatistics
Pharmaceutical

Please refer to the company's website or job descriptions to learn more about them.

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