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Manager Biometrics

Assure compliance with reference qualification program standards and procedures; assist in experimental assay & clinical study design protocols to generate the best statistically relevant data package (i.e., reference curve calibration, reagent replacement, clinical study optimization, ELISA re-development including release and serology testing, and reference stability monitoring assays). Coordinate the data collection & write the mid-date reference stability report for submission to USDA.

Provide a biometrics analysis where appropriate for data generated to support validation of processes, test methods, and to support clinical studies. Participate on Reference Qualification teams to provide biometrics support & obtain thorough understanding of study objectives. Defend the data and statistical analysis to internal management and to regulatory agencies. Participate in influencing the agency with regard to the appropriate statistical models for in-vivo and in-vitro studies.

Qualifications:
MS in Statistics with a minimum of 7 years of relevant experimental design and analysis experience. Experience in a science-based research or industry setting. Thorough understanding of experimental design and mixed linear/non-linear methodologies. General understanding of immunoassays and/or clinical study design. General understanding of contemporary & traditional bacteriology & virology techniques, and validation principles.

In-depth knowledge of contemporary statistical analyses used to evaluate analytical & clinical studies. Demonstrated experience with SAS and possess excellent data management skills.. Knowledge of USDA, FDA, and EU regulations, Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs).

Demonstrated ability to write and review technical documents with demonstrated high level of attention to detail. High integrity and self motivation. Strong communication (oral and written), interpersonal, and team/group interactive skills. Experience with communicating statistical analyses to a variety of skilled and unskilled audiences.

Preferred Qualifications:
PhD in Statistics with experience in biostatistical analyses of immuno-, biochemical, or molecular biological assays, and clinical studies. Experience with USDA biometrics standards and thorough knowledge of 9CFR 113.8 & reference qualification. Prior Lean methods training. Certified in RFT Six-sigma applications.

Throughout our 153 years, a legacy of caring for others has been at the heart of everything we do at Pfizer. This commitment is no less important when it comes to our employees. Pfizer wants to ensure that employees have resources to help them develop and succeed both in their careers and personal lives. One way we can achieve this is through our comprehensive benefits program, which offers employees and their eligible dependents the variety and flexibility to help address their needs at different stages in life.

Pfizer Inc. discovers, develops, manufactures, and markets leading prescription medicines for humans and animals. Our innovative, value-added products improve the quality of life of people around the world and help them enjoy longer, healthier, and more productive lives. The company has two business segments: health care and animal health. Our products are available in more than 150 countries.

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 employment eligibility verification requirements of the Immigration and Nationality Act.

All applicants must possess or obtain authorization to work in the U.S. for Pfizer. Pfizer retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified U.S. workers. Individuals requiring sponsorship must disclose this fact.

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