The Office of Biostatistics is seeking individuals with strong statistical methodology skills and an interest in biomedical applications to serve as mathematical statisticians. Incumbents work with multidisciplinary teams of review scientists in a dynamic, highly challenging, and innovative atmosphere of development, evaluation, and research of drug and therapeutic biologics. The Office of Biostatistics is responsible for reviews in all therapeutic areas CDER supports and can be as diverse as cardio-renal, oncology, and antimicrobial products. Incumbents have an opportunity to employ a broad variety of statistical procedures relevant to pre-clinical and clinical evaluation decisions for new and generic drugs as well as new and biosimilar biologics and the emerging fields of quantitative risk assessment and pharmacogenomics.
Evaluate and advise on protocols for clinical studies and assess the evidence for safety and efficacy from clinical studies submitted in drug and biologics applications
Employ a broad variety of statistical procedures relevant to pre-clinical and clinical evaluation decisions for new and generic drugs as well as new and biosimilar biologics and the emerging fields of quantitative risk assessment and pharmacogenomics.
Work with multidisciplinary teams of review scientists in a dynamic, highly challenging, and innovative atmosphere of development, evaluation, and research of drug and therapeutic biologics.
Refine your consulting, communication, and presentation skills and present at domestic and international professional meetings.
Engage in an active collaborative regulatory research program which will allow you to advance your skills and professional development.
Interact with national, international, public, and private organizations on statistical issues, and help develop guidance for the pharmaceutical industry.
Applicants should possess an advanced degree with specific coursework in Statistics, Biostatistics or Mathematical Statistics. Applicants with a doctoral degree and associated experience are highly desirable. In addition to a background in statistics, applicants should have an interest in biostatistics, clinical trials, epidemiology, genomics, or risk assessment.
The ability to communicate statistical issues to non-statisticians is vital.
10 openings. Telecommuting is allowed.
Internal Number: 1529
About U.S. Food and Drug Administration
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
Under the Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), the Office of Biostatistics (OB) is recognized for excellence in the application and communication of statistical science in drug regulation and development. We play a central role in promoting innovative, science-based, quantitative decision-making throughout the drug development life-cycle. To support CDER’...s mission, we provide statistical leadership, expertise, and advice to ensure that safe and effective drugs are available to the American people.
FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.