Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
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 Biologics & Evaluation Research (CBER) - Regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. To ensure the safety, purity, potency, and effectiveness of biological products.
Center for Drug Evaluation & Research (CDER) Provide regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products.
Center for Devices and Radiological Health (CDRH) - Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Center for Food Safety and Applied Nutrition (CFSAN) - Responsible for the safety of the nation's domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.
Center for Tobacco Products (CTP) - Responsible for implementing the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products and manufacturers based on the best available science and for both assessing and fostering that science base.
Office of Regulatory Affairs (ORA) Inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States.
National Center for Toxicological Research (NCTR) - Provides the field offices with coordinated direction, assistance, and management for investigational activities in international arenas.
Center for Veterinary Medicine (CVM) - Conducts research that helps FDA ensure the safety of animal drugs,
food for animals, and food products made from animals; and monitors the safety
and effectiveness of animal drugs on the market.
Who May Apply: Open to all United States Citizens.
Additional selections may be made within the same geographical area FDA-wide.
- Not Required
- U.S. Citizenship is required.
- Only experience gained by closing date announcement will be considered.
- One year probationary period may be required.
- Official transcripts required.
A. In accordance with OPM's qualifications standards, the following basic requirements must be met in order to qualify for this position: Degree: that included 15 semester hours in statistics (or in mathematics and statistics, provided at least 6 semester hours were in statistics), and 9 additional semester hours in one or more of the following: physical or biological sciences, medicine, education, or engineering; or in the social sciences including demography, history, economics, social welfare, geography, international relations, social or cultural anthropology, health sociology, political science, public administration, psychology, etc. Credit towards meeting statistical course requirements should be given for courses in which 50 percent of the course content appears to be statistical methods, e.g, .course that included studies in research methods in psychology or economics such as tests and measurements or business cycles, or courses in methods of processing mass statistical data such as tabulating methods or electronic data processing.
B. Combination of education and experience-courses as shown above, plus appropriate experience or additional education. The experience should have included a full range of professional statistical work such as (a) sampling, (b) collecting, computing, and analyzing statistical data, and c) applying statistical techniques such as measurement of central tendency, dispersion, skewness, and sampling error, simple and multiple correlation, analysis of variance, and tests of significance.
Evaluation of Education:
Courses acceptable toward meeting the mathematics course requirements of paragraphs A or B above must include at least four of the following: differential calculus, integral calculus, advanced calculus, theory or equations, vector analysis, advanced algebra, linear algebra, mathematical logic, differential equations, or any other advanced course in mathematics for which one of these was a prerequisite. Courses in mathematical statistics or probability theory with a prerequisite of elementary calculus or more advanced courses will be accepted toward meeting the mathematics requirements, with the provision that the same course cannot be counted toward both the mathematics and the statistics requirements.
Specialized Experience Requirement:
In addition to the basic requirement, applicants must possess one (1) year of specialized experience equivalent to at least the GS-7 level in the Federal Government, experience includes but not limited to:
Performing statistical analysis, reports, spreadsheets, and data management for accuracy of statistical studies and projects; professional statistical work such as data management and analysis of statistical data utilizing statistical software; statistical procedures such as measurement of central tendency, dispersion, sampling error, analysis of variance, tests of significance, and survival analysis, preparation of statistical documentation to justify results of statistical surveys and studies; compiling numerical and/or statistical data.
Possess a Master's degree. The following are examples of acceptable graduate courseswork: Linear models, survival analyses, statistical computation (SAS, R, etc), statistical consulting, statistical influence, clinical trials.
2 full years of progressively higher level graduate education leading to such a degree and includes examples of coursework listed under "Master's Degree"
You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.
Conditions of Employment:
1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.
2. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
4. Pre-employment physical required: No
5. Drug testing required: No
6. License required: No
7. Mobility agreement required: No
8. Moving expenses authorized: may be authorized.
9. Immunization required: No
10.Relocation Incentive may be authorized.
11. Recruitment Incentive may be authorized.
12. Retention incentive may be authorized upon the completion of one year of FDA federal experience, satisfactory completion of a probationary/trial period, and upon receipt of an "Achieved Expected" or higher performance rating.
13. Student loan repayment incentive may be authorized.
14. Annual leave for non-federal service may be authorized.
15. Bargaining Unit Position: Yes
16. Please be advised that this position will be subject to FDA's strict prohibited financial interest regulation and therefore, may require the incumbent of this position to divest of certain financial interests. Applicants are strongly advised to seek additional information on this requirement from the FDA hiring official before accepting this position.
The incumbent collaborates with statistical reviewers and management on a variety of computationally intensive projects to support and improve the efficiency of regulatory product review and applied regulatory research. The incumbent works with multidisciplinary teams of scientists and a diverse array of stakeholders in a dynamic, highly challenging, and innovative atmosphere.
Working with division's management, team leaders and statistical reviewers, the incumbent plays a critical role in supporting the mission of advancing the product review process.
Works with the team leader and the statistical reviewer to provide statistical programming and data management support for review of the evidence related to an applicant's claims regarding safety, efficacy and benefit-risk in New Drug Applications (NDAs), Biologic License Applications (BLAs), and supplemental and abbreviated applications (sNDAs; ANDAs); assesses the quality and completeness of submissions with assistance from team leader and/or reviewer; prepares clinical trial analysis datasets; assists with communication with applicants regarding specifications for regulatory information requests; validates sponsor results; produces required tables, listings, and figures
As requested by senior staff, assists in analyzing epidemiological/observational data from health records, registries, natural history studies and contract databases to answer review questions concerning the life-cycle safety, efficacy and use of regulated drugs and biologics; assist in designing and producing code for methods development under the Sentinel initiative and other related programs, including Sentinel safety queries and assists in routine surveillance studies.
Assists in applying, documenting and archiving programs, processes, procedures and SOPs for management and handling of review and research data files and databases created and/or used by OB statistical reviewers for decision support and regulatory science research; assist in developing special-use databases; imports and exports data into specified formats using established fire-walled Agency servers; assists in implementing transformations needed to input clinical trial into data special use.