Director, Biostatistics - Rare Disease

Employer
Pfizer
Location
Cambridge, MA
Posted
Jun 15, 2022
Ref
4835163
Required Education
Masters Degree/MBA
Position Type
Full time

ROLE SUMMARY

The Director of Biostatistics will provide statistical leadership in one or more rare disease therapeutic areas (hematology, cardiology, nephrology, metabolic, or neurology), including oversight of pre-clinical and clinical development planning and execution for multiple indications in Pfizer’s expanding Rare Disease Research Unit. The position will oversee coordination of statistical support efforts across numerous indications and therapeutic modalities (gene therapy, mRNA, small molecule, and biologics). In addition to accountability for the robust planning and execution of (pre-)clinical development programs, the Director will provide strategic leadership in relevant statistical areas such as external control matching, composite endpoint development, and other topics inherent in small-sample drug development.

ROLE RESPONSIBILITIES

  • Collaborate with various cross-functional scientists in the design, analysis and reporting of laboratory and early clinical studies in rare diseases

  • Provide statistical leadership in one or more therapeutic areas, including hematology, cardiology, nephrology, metabolic, or neurology

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

  • Interact withinternal 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 in the rare disease setting is the systematic review and incorporation of prior information (utilizing Bayesian methods as appropriate), statistical model building and simulation, and rigorous and robust use of external historical control data

  • Frequently 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

  • Mentor, train, and manage junior level staff

QUALIFICATIONS

  • MSc (PhD preferred) 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) and translational experience in rare disease indications a definite advantage

  • Experience with modeling and simulation and expertise in Model Informed Drug Development (MIDD) principles

  • Demonstrated strong communication skills, both oral and written

  • Ability to 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

OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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