The U.S. Food and Drug Administration, located in Silver Spring, Maryland, is seeking candidates to fill Statistician positions in the Office of Biostatistics (OB). 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 our Center’s mission, we provide statistical leadership, expertise, and advice to ensure that safe and effective drugs are available to the American people.
Work with a multidisciplinary review team to provide statistical programming and data management support, assess the quality and completeness of submissions, prepare clinical trial analysis data sets, validate sponsor results, assist in modeling and simulation, and suggest possible additional statistical analyses required to fully evaluate the evidence in the submission.
Collaborate with scientists from the Office of Pharmaceutical Quality, statistical reviewers in OB, and management on a variety of computationally intensive projects to support and improve the efficiency of regulatory product review, evaluation of pharmaceutical quality and applied regulatory research.
Use machine learning and natural language processing to assess internal and external data sources to support assessment of quality intelligence throughout the product life cycle.
Develop, validate, implement, document, maintain and support programming tools and software according to standards and accepted validation procedures; Support efforts to develop, document and apply reusable code and/or tools.
Develop software using the appropriate statistical programming packages for statistical reviewers to support programming-intensive review-related activities such as sensitivity analysis, Bayesian approaches, clinical trials modeling, genomic studies, psychometric Clinical Outcome Assessment (COA) validation, and simulation.
Promote and improve the Center data standards initiatives mandated by the Prescription Drug User Fee Act; Monitor the quality of the implementation of data standards used in New Drug Application submissions.
Apply your skills to address unique and precedent setting problems, while refining your consulting, communication, and presentation skills.
Candidate must meet the Office of Personnel Management (OPM) Individual Occupational Requirements (IOR) for Statistics Series, 1530. Please click here to review the requirements.
Familiarity with R, SAS, data science tools, machine learning predictive techniques and natural language processing.
Experience in clinical trials, epidemiology, genomics, or risk assessment.
Strong skills in multiple programming environments.
Excellent oral and written communication skills.
Ability to communicate statistical issues to non-statisticians.
10 openings. Telecommuting is allowed.
Internal Number: 1530
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.