Job Description

ROLE SUMMARY

The Associate Director of Biostatistics will provide statistical support in one or more rare disease therapeutic areas (hematology, cardiology, nephrology, metabolic, or neurology), including pre-clinical and clinical development planning and execution for multiple indications in Pfizer’s expanding Rare Disease Research Unit. The position will be accountable for the robust planning and execution of (pre-)clinical development programs across numerous indications and therapeutic modalities (gene therapy, mRNA, small molecule, and biologics). The Associate Director will provide strategic input and 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

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

Contribute to 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

QUALIFICATIONS

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.?

MSc (PhD preferred) in Statistics, Biostatistics, or related field

Minimum of 6 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 competency with the design, implementation, analysis and reporting of clinical trials