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.
Basic Requirement: Applicants must meet one of the following:
A. 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 toward meeting statistical course requirements should be given for courses in which 50 percent of the course content appears to be statistical methods, e.g., courses 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 in A above plus appropriate experience or additional education. 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, sampling error, simple and multiple correlation, analyses of variance, and tasks of significance.
Evaluation of Education:
All applicants must submit unofficial transcripts to receive consideration and confirm that you meet the basic education requirements of the position. Unofficial transcripts are issued by the registrar's office at your college or university and have the following information listed:
· name of the college or university, a watermark and/or the school seal
· the month and or year when you officially began and ended your coursework
· the name of program/major/curriculum of study
· the timeframe in which the semester/quarter courses were taken
· the total credit hours and grades earned for each course
Self-generated course lists or print outs from your student account are not acceptable. Additionally, please submit all transcripts that may help you met the basic education requirement. For example, if you have a Ph.D or Master's degree please provide copies of those transcripts as well as transcripts from previous degrees that may illustrate you met some or all of the basic education requirements. If you have more than one degree, please save/scan each transcript separately.
Specialized Experience Requirement:
In addition to the basic requirement, you must have one (1) year of specialized experience to at least the GS-11 level in the Federal Government, performing planning, execution, and data management for major statistical studies and projects; ensuring accurate and timely data management and data analyses for clinical data; experience should have included a full range of professional statistical work such as (a) sampling, (b) data management and analysis of clinical trial or other clinical data, (c) applying statistical techniques such as measurement of central tendency, dispersion, sampling error, analysis of variance, tests of significance, and survival analysis, and (d) assisting in conducting statistical studies on research problems and assisting in presentation of results at scientific meetings.
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 FDAs 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 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; prepares clinical trial analysis datasets; interprets the applicant's programs; assists with communication with applicants regarding specifications for regulatory information requests; validates sponsor results; produces required tables, listings, and figures. Suggests possible additional statistical analyses required to fully evaluate the evidence in the submission.
Analyzes 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; with support from senior staff, designs and produces code for methods development under the Sentinel initiative and other related programs, including Sentinel safety queries and assists in routine surveillance studies.
Working with division management, team leaders and statistical reviewers, the incumbent plays a critical role in supporting the OB mission of advancing the product review process.
Assist in assessing requirements and assumes primary responsibility in the design and validation of statistical programming code to apply quantitative and graphical approaches within the regulatory review and research environment. Assist in developing statistical programming solutions across projects and/or technologies to meet internal regulatory review and research needs. Plans and coordinates statistical programming for complex studies; develops, validates, implements, documents, maintains, and supports programming tools and software in accordance with standards and accepted validation procedures. Supports efforts to develop document and apply reusable code and/or tools. Develops software using the appropriate statistical programming packages (e.g., R, JAGS, SAS ) for OB 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.
Works with statistical reviewers to design and conduct analyses of data from clinical trials, observational databases, natural history, pharmacokinetic and genomic studies, special surveys, and simulated data in order to study statistically intractable problems Writes reports and papers to support a wide range of OB regulatory science activities in FDA. Provide programming support for innovative graphical displays suggested by review staff.
Designs and programs data checks, as needed, to facilitate data quality and integrity. Inspects data received from sponsors and other sources for problematic entries and missing values. Evaluates and reports quality of submitted clinical trials data and the data from large safety databases. Monitors the quality of the implementation of data standards used in applicant submissions. Supports FDA projects to develop and maintain a capability for assessing and reporting on the