Associate Director, Biostatistics Oncology

Employer
Pfizer
Location
La Jolla, California
Posted
May 16, 2022
Ref
4844906
Required Education
Masters Degree/MBA
Position Type
Full time

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 and 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 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 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

Basic Qualifications

  • M.S. degree in Statistics or Biostatistics with minimum 5 years’ relevant experience, or PhD in Statistics or Biostatistics at least 3 years’ relevant experience in applying statistics in a pharmaceutical or related industry.

  • Exposure to the design and analysis of clinical studies in both early and late-stage clinical development.

  • Excellent statistical knowledge with the ability to apply this to scientific and clinical problems

  • Experience with modeling and simulation in early clinical development

  • Experience in using Bayesian methods to scientific research

  • 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.

  • 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.

Preferred Qualifications

  • 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.

OTHER JOB DETAILS

  • Eligible for Relocation Package

  • Eligible for Employee Referral Award

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.

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