This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in Montgomery County, MD. Positions may be filled in the following Centers: Center for Tobacco Products (CTP), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM), Center for Food Safety and Applied Nutrition (CFSAN), and Office of Regulatory Affairs (ORA), Office of Operations (OO), Office of Commissioner (OC), and National Center for Toxicological Research (NCTR).Learn more about this agency
The incumbent may perform the following responsibilities: For positions within CDER/CDRH/CBER: Serve as an expert in statistical methodology and review statistical methods for the analysis of data, primarily from clinical studies. Provide statistical regulatory support, evaluating and suggesting changes to clinical trial protocols, statistical methods, clinical trial design/conduct issues, and analyze data from clinical studies using specialized statistical software and general programming languages. Act as statistical consultant for a range of other problems, e.g. manufacturing quality, laboratory experimental design/analysis, survey statistics, psychometrics, epidemiology, decision analysis, quantitative risk analysis, Collaborate with other scientists in the evaluation of regulated studies and the conduct of primary research activities. Suggest changes to clinical trial protocols, including statistical methods, trial design and conduct issues. Perform statistical reviews of investigational applications such as Investigational New Drugs (INDs), Investigational New Animal Drugs (INADs) and Investigational Device Exemptions (IDEs), by evaluating proposals for the design, conduct, and analysis of regulated clinical studies. Perform statistical reviews of marketing applications such as Biologics License Applications (BLAs), New Drug Applications (NDAs), New Animal Drug Applications (NADAs), Premarket Approvals (PMAs) and Premarket Notifications [510(k)s] submissions and supplements for adequacy of design, conduct, analysis, and appropriateness of resulting inferences and conclusions. Verify applicants' critical statistical analyses and perform additional analyses as needed. Suggest and verify methods and analyses in pilot studies, clinical trials, laboratory studies and other research projects to ensure validity of inferences obtained from these studies. Represent the FDA in meetings and keep abreast of progress and potential problems. Work in collaborative multidisciplinary groups with scientists, engineers and physicians, translating medical questions and concerns into appropriate statistical analyses and communicating results. Collaborate with statisticians from sponsor companies and academic statisticians to develop new statistical methods and learn about new methods as they are being developed. Write summaries and develop reports and papers regarding statistical or clinical trial issues; give briefings/presentations to other statisticians, colleagues, FDA advisory panels, and upper management. Attend conferences to retain and enhance professional competency, and participates in activities of relevant professional societies.
For Positions within CFSAN: Provide statistical regulatory support, evaluate and analyze data from designed experiments, surveys, and observational studies using computational methods. Independently lead individual team effort to plan a statistical survey or study; develop novel statistically defensible solutions to technical issues; analyze large databases using signal detection, data and text mining methodology. Coordinate with CFSAN's Office of Compliance and FDA's Office of Regulatory (ORA) statisticians to develop sampling and inspection workplans for FDA field laboratories and investigators. Verify and validate methods and computations in pilot studies surveys, experiments, laboratory studies and final projects to assure the accuracy validity of results obtained from data obtained from these efforts. Design and analyze complex surveys and/or large multi-laboratory experiments; design experiments after consulting with project teams; select appropriate statistical methods for modeling and estimate generation, performing testing to identify outliers and assess departures from distributional assumptions, etc.
For Positions within CTP: Evaluate and integrate data from complex probability-based surveys, observational studies, designed experiments, and analysis of data from large dataset/databases; use mathematical and statistical programming and data processing using programs such as R/S-plus, C++, Matlab, Stata, Java, Perl and SAS; design biological and chemical experimental studies; provides support for microbial and chemical assay and method development. Conduct analysis of complex population level surveys, population projection modeling and micro-simulation models; ecometrics; econometrice dynamical systems, and systems biology simulation.
For Positions within CVM: Provide expertise, leadership, and coordination across the Center evaluating study protocols and review results from studies investigating the effectiveness and safety of animal drugs, food/feed, food additives, and other related applications. Provide statistical consultation for effectiveness and safety studies, research projects, and other work. Use statistical and mathematical methods to draw inferences from data and to facilitate the Center's scientists in study design, data analysis, and data interpretation.
Who May Apply
This job is open to…All U.S. Citizens
Job family (Series)
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/487644100. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.