Director, Biostatistics, Early Clinical Development

Pfizer La Jolla , CA 92037

Posted 4 days ago

Biostatisticians play a critical role in the advancement of new medicines at Pfizer. The right candidate will partner with senior management, clinicians, clinical pharmacologists, translational medicine, and other scientists to support early clinical development for Oncology. The statistician will be involved in the design, execution, analysis, and reporting phases of clinical protocols and provide statistical expertise on regulatory submissions and ensure the quality and appropriateness of submission deliverables. She/he will support the development of innovative and efficient plans for developing new medicines in a variety of cancer indications. She/he will review scientific literature, promote innovation, efficient design and quantitative decision-making within research and in partnership with other lines, reducing the time and cost of drug development.

Biostatisticians play a critical role in the advancement of new medicines at Pfizer. The right candidate will partner with senior management, clinicians, clinical pharmacologists, translational medicine, and other scientists to support early clinical development for Oncology. The statistician will be involved in the design, execution, analysis, and reporting phases of clinical protocols and provide statistical expertise on regulatory submissions and ensure the quality and appropriateness of submission deliverables. She/he will support the development of innovative and efficient plans for developing new medicines in a variety of cancer indications. She/he will review scientific literature, promote innovation, efficient design and quantitative decision-making within research and in partnership with other lines, reducing the time and cost of drug development.

Roles and 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 with internal 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

The qualified candidate must have a M.S. or Ph.D. in Statistics, Biostatistics, or related field, as well as a minimum of 6 years experience in applying statistics in a pharmaceutical or related industry. Ideally, this experience would include exposure to the design and analysis of clinical studies in oncology early clinical development. The preferred candidate will have excellent statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, and Bayesian statistics. The preferred candidate will have a proven ability to manage multiple complex projects with a track record of influencing external environment through contributions to scholarship, working parties etc., as evidenced by committee membership, presentations and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical methodologies.

Strong communication skills with the ability to influence widely and work collaboratively with clinical project teams and senior management are required.

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.

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.

Additional Offer Details:

  • Last Date to Apply for Job: December 15, 2017

  • This job is Pfizer Exempt (US/PR) Grade: 016

  • Additional Location Information: Cambridge, MA

  • Eligible for Relocation Package: yes

  • Eligible for Employee Referral

    Bonus:
    yes

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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Director, Biostatistics, Early Clinical Development

Pfizer