Associate Director, Biostatistics, Early Clinical Development, Rare Disease

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
  

OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Medical