Pfizer Associate Director, Early Clinical Development, Biostatistics in La Jolla, California

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 developed by Pfizer early Oncology research unit. 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.

  • Collaborate with various scientists in the design, analysis and reporting of early clinical studies.

  • 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.

  • 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

Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.

Scientific Qualifications

  • M.S. or PhD in Statistics or related disciplines as well as a minimum 3 years (5 years for M.S.) of experience of applying statistics in a pharmaceutical or related industry

  • Experience applying statistical methods to the prospective design and analysis of scientific and/or clinical problems. Pharmaceutical applications desired, with early clinical (phase I and phase II) and translational experience a definite advantage. Prior experience providing statistical support to clinical studies in oncology is a plus. Either experience in using or sound understanding of the value of Bayesian methods to scientific research.

  • Experience running simulations and mixed models.

  • Experience with multivariate statistics and statistical methods to quantify uncertainty in multi-dimensional data

  • Demonstrated strong communication skills, both oral and written.

  • Demonstrated ability to work effectively as a part of a team.

Technical Skill Requirements

  • Must have R or SAS programming skills

  • Must be able to explain statistical techniques and considerations to non-statisticians

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.

Other Job Details:

  • Last Date to Apply for Job: July 1, 2018

  • 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.