Director, Nonclinical Biostatistics

Employer
Pfizer
Location
Pearl River, New York
Posted
Jun 15, 2022
Ref
4852701
Required Education
Doctorate/PHD/MD
Position Type
Full time

Role Summary

Pfizer's Early Clinical Development Statistics organization is looking for a motivated and experienced statistician with a solid background in nonclinical statistics, strong consulting skills, and an interest in collaborating with research scientists in drug discovery and development. The statistician in this role will work closely with research scientists seeking to discover new medicines in a variety of therapeutic areas by supporting the design and analysis of preclinical experiments covering all aspects of drug discovery from disease target identification, pharmacology studies, animal model development, biomarker development and demonstration of proof-of-concept. The focus will be on both “platform” approaches (i.e. ensuring robust assay methods) as well as specific project approaches. The ideal candidate will have a genuine interest in understanding drug target biology in order to provide effective statistical consultation with biological scientists, as well as effective communications with lab managers and regulators.

Role Responsibilities

  • Drive collaborations with vaccine assay specialists to support vaccine clinical and diagnostic assay development, qualification, and validation

  • Drive collaborations with vaccine preclinical scientists to support vaccine preclinical and nonclinical development

  • Ensure statistical rigor and good scientific practices are followed, excellent statistical methods utilized, and documented in protocols, analysis plans and manuscripts

  • Provide statistical expertise to regulatory submissions and ensure quality and appropriateness of submission deliverables

  • Lead innovative statistical thinking and methods to maximize the value of aggregate clinical and preclinical data in support of scientific and vaccine development strategies

  • Serve as a core member of scientific teams responsible for determining strategy and delivering results in a timely and high-quality manner

  • Where possible, standardize processes and methodologies, may include developing statistical tools to aid scientists in standardized analyses.

  • Use statistical expertise to prepare both internal and external reports, presentations and manuscripts, with the aim to improve the quality of internal decision making and increase our influence on the external environment

  • Mentor and train junior level staff

Qualifications

Must-Have

  • PhD in Statistics/Biostatistics and at least 6-10 years of pharmaceutical experience or a Master degree in Statistics/Biostatistics and at least 10-15 years of pharmaceutical experience

  • Strong pre-clinical and non-clinical experience is required

  • Must have strong technical competence, including statistical computing and modeling

  • Capability to provide statistical leadership to cross-functional teams

  • Sound understanding of design of experiments, assay development, and statistical applications for preclinical research

  • Good knowledge of drug development regulations pertinent to statistical analysis

  • Demonstrated strong communication skills, both oral and written

  • Preferred candidates will have good computational skills in SAS and R

  • Ability to work collaboratively with research scientists are essential

  • Demonstrated ability to work effectively as a part of a teamand proactively influence teams with innovative assay development and validation strategy

  • 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.

Nice-to-Have

  • Assay validation experience, particularly clinical assays, is highly desired

  • Vaccine development experience is highly desired

  • Experience responding to regulatory queries is desired

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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