The Epidemiology Regulatory Science Program (ERSP) is a combined intramural/extramural program in the Division of Epidemiology (DEPI), Office of Surveillance and Biometrics (OSB), a component of FDA’s Center for Devices and Radiological Health (CDRH). The ERSP serves as the Core of the FDA Medical Device Epidemiology (MDEpiNet) Program (providing leadership, support and coordination of the FDA funded MDEpiNet research projects.
ERSP/MDEpiNet builds on a research infrastructure that includes a variety of organizations, collaborations, and databases, and it conducts independent research on marketed medical devices in support of CDRH regulatory decisions, including studies on safety and effectiveness, utilization and public health impact.
The ERSP/MDEpiNet helps fulfill important CDRH goals by:
- developing and applying novel methodologies and infrastructure for device studies and surveillance;
- monitoring marketed medical devices and radiation-emitting devices for continued safety and effectiveness;
- disseminating accurate, science-based information on device performance; and
- contributing to medical device regulatory efforts
Below is a listing of the fellowship appointments offered through the CDRH Postgraduate Research Participation Program and is administered by the Oak Ridge Institute for Science and Education (ORISE). The program is open to all qualified U.S. and non-U.S citizens without regard to race, color, age religion, sex, national origin, physical or mental disability, or status as a Vietnam-era veteran or disabled veteran. The individual selected for appointments will not become employees of ORISE, ORAU, DOE, FDA, CDRH, or any other office or agency. Program participants will be paid a monthly stipend. The participants may be located at any FDA-approved location.
The candidate must have authorization to work in the United States and be willing to work on-site at the White Oak Campus, Food and Drug Administration (FDA), Silver Spring MD.
The following ORISE Fellowship Vacancies are currently Open until filled.
How to Apply: Send Resumes to DEPIrecruitment@fda.hhs.gov. Please make sure your name and the position/project title you are interested in are placed in the subject line of the email.
If you are identified as a qualified candidate, you will be contacted and sent an ORISE Application package to complete. Please direct any questions to the email DEPIrecruitment@fda.hhs.gov
Please note all vacancies are open until filled.
The individual will be responsible for the data analysis and support and coordination of data and information acquisition, evaluation, and dissemination for priority medical devices within the MDEpiNet collaboration and partnership.
- Conduct research to develop methodologies, approaches analyzing data and presenting findings.
- Provide expertise in the design, management and evaluation of study protocols, analysis, and interpretation of study results.
- The candidate must have Master’s Degree work in Epidemiology with training and experience in performing analyses of medical product exposure and outcome using administrative claims data sources.
2. Database Programmer - Multiple positions are available
- Develop system for cataloging and accessing data sets from multiple sources with inconsistent data standards. This system should allow for data sources to be added and updated on a regular basis and facilitate regular statistical analyses.
- Work with stakeholders throughout FDA and MDEpiNet partners to access and update data sources used for medical device epidemiology.
- Computer Science or a related discipline
- The candidate must be working toward or hold a Bachelor’s degree or higher degree in Computer Science, Epidemiology, Statistics, Biostatistics, or a related discipline.
- Must have experience in data management and be able to apply advanced statistical techniques to the analysis of existing data from studies and registries.
- Experience programming in C, C++, SQL, MATLAB, or similar languages.
- Experience working with complex data structures in distributed and federated networks.
- Experience designing, developing, programming, implementing, populating, and analyzing relational databases.
3. Junior Level Research Assistants – Multiple positions are available
- The assistant will conduct research synthesis to provide both summary and detailed reviews of the data available on medical devices. Data included in this research are the following: (a) premarket device data regarding substantial equivalence or safety and effectiveness; (b) post market experience known through adverse event reporting, s, post-approval studies, registry data, and administrative medical data; (c) review of peer-reviewed, published literature; (d) review of published documents not in scientific/clinical journals (i.e. “gray” and “white” literature).
The projects will take part in stages: Systematic review of published literature on medical devices
- Using knowledge gained from systematic review of premarket and postmarket data, determine search terms needed to adequately capture medical devices in systematic literature review
- Determine appropriate articles for review using pre-established criteria
- Abstract data
- Synthesize all data into knowledge-summary documents.
- The candidate must have a Master’s Degree work and experience in performing literature reviews.
4. Epidemiologist – Multiple positions are available
- The individual will be responsible for the data analysis, coordination of data, evaluation, and dissemination for priority medical devices within the MDEpiNet collaboration and partnership. Coordination of data, resources, and communication efforts are key aspects to this research program.
- Doctoral degree in Epidemiology with background in biostatistical analysis, data management, and experience in advance epidemiologic methods (e.g. propensity score modeling)
5. Information Research Analyst
To research and analyze the best uses of the massive amount of structured, semi-structured, and unstructured medical and health information that is created and stored across a wide variety of repositories at FDA’s Center for Devices and Radiation Health (CDRH.) These repositories hold research, regulatory science, and other classes of information which may be records, and related documents, information, and data. A robust Information Management Architecture and Governance is needed to guide CDRH staff on what, where and how information should be stored and accessed. The information architecture should be tailored to address CRRH’s research, staff, and stakeholders’ needs.
The research analyst will help identify how and which information is currently used, what are the gaps in research information and help identify how the research data fits together to stream-line the process. The results of this research will be synthesized into knowledge summaries with detailed view of all the data available. The analysis and summaries of the research data will be used to help locate and utilize the data for research efforts and analysis at CDRH. The outcome of this project will also help shape the information policy which will facilitate the findability, searchability, records management, and knowledge management at the Center. Better information will help make timelier and more relevant decisions, use CDRH’s existing data more effectively, reduced confusion and frustration, and facilitate research activities at CDRH. In this research project we will explore and discover ways to make the process of regulatory research more collaborative, streamlined and effective.
The ideal candidate will have an engineering, health sciences, medical, information management or technology background and experience
- Master or Bachelor’s degree in Science – Such as Engineering, Management or Biology with concentration in Information Management, Healthcare Informatics, Computing, Library Science, Journalism, Statistics, Epidemiology, or related fields
- Ability to document process flows, policies and procedures
- Ability to present complex information in understandable and compelling manner
Outstanding writing and PM skills
Epidemiologist Staff Fellow
How to Apply: Send Resumes to DEPIrecruitment@fda.hhs.gov. Please make sure your name and the position/project title you are interested in are placed in the subject line of the email. If you are identified as a qualified candidate, you will be contacted and sent a Staff Fellow Application package to complete. Please direct any questions to the email DEPIrecruitment@fda.hhs.gov
Duties and Responsibilities:
The incumbent works as part of a team in conducting Epidemiology studies and is responsible for the management of the regulatory activities of the team including conducting meetings, and preparing issue-based agendas and official meeting records.
The incumbent is responsible for developing, analyzing and identifying epidemiology public health issues and their impact on public policies or scientific studies and/or surveys. Participates with other scientists and program consultants both in various aspects of the study or project design process which may include conducting search or reviewing existing literature and data in a scientific area and preparing and/or presenting summaries for a variety of purposes, monitoring, designing questionnaires and other data collection documents. The incumbent utilizes epidemiological knowledge to conduct technical analysis of work done by others. Assists in the development of agency policy and regulations. Provides epidemiological scientific advice and technical assistance to various public, private, and/or nonprofit health and/or health-related agencies and organizations for specific programs or issues where the type of resources provided, and/or the impact on communities is extensive.
Incumbent works with all members of the team to develop project plans, including setting time frames, milestones and an agreed upon endpoint. Participates in ensuring the timely completion of project activities and attainment of project objectives within established and specified regulatory plans and performance goals set by FDA and the team. Manages and coordinates the work of the team members for the specific epidemiology scientific regulatory process in order to determine how much progress is being made and if any problems are surfacing. The incumbent may recommend reevaluation of team membership and workload redistribution, if found necessary. Monitors and reports actual status of all activities within the assigned scientific regulatory projects through interaction with project participants and, if required, supervisors and Directors.
Provides technical consultation and assistance to all parties engaged or interested in the FDA scientific regulatory process concerning epidemiology studies including various public, private, and/or nonprofit health and/or health-related agencies and organizations. Opinions are often precedent setting and conveyed decisions which may have major public health and/or economic consequences to the regulated industry. Uses scientific and technical methods and practices to identify and evaluate a wide range of health conditions in a specialty area.
Serves as a focal point contact for technical inquiries concerning regulations, policies and procedures and ensures compliance with all legal, regulatory and policy requirements.
The incumbent draws upon a comprehensive knowledge of the regulations, the historical aspects, and related matters to anticipate and identify subtle or obscure problems and to ensure that the team is aware of these problems and addresses them as needed.
Participates as a technical regulatory industry contact for all epidemiological scientific issues on the project in study. Responsible for communicating directly with regulated industry counterparts to resolve issues, facilitate technical information gathered for reviewers and regulators, and explain all current regulatory requirements for the epidemiological scientific project.
Assists in the writing of comprehensive statistical and analytical reports from major epidemiological studies and collaborates with other scientists, analysts and statisticians to develop a joint analyses and any other required publications.
Responsible for industry compliance with and tracking of all regulatory requirements of FDA legislation including FDAAA. Responsible for ensuring the regulatory aspects of Good Review Management Principles and Practices (GRMPPs) and the appropriate in one of the Centers goals and deadlines are accomplished according to regulatory mandates. The incumbent is responsible for communicating and explaining all regulatory requirements to managers, industry, and applicants as well as coordinating compliance with any regulatory findings and recommendations.
Responsible for tracking and regulating all necessary processes and guidelines being managed. Utilizes statistical techniques commonly used in epidemiologic evaluations to interpret and analyze observed health phenomenon. Performs statistical analysis as part of a segment of a nationwide data collection and analysis when necessary. Responsible for ensuring the statistical validity and epidemiologic applicability of study activities by solving problems occurring in the data collection process. Efforts include the identification and evaluation of data implications and limitations relative to the problem under study.
Performs other specialized duties related the supported area.
Currently we do not have any summer research positions available, but you may submit your CV for consideration to DEPIrecruitment@fda.hhs.gov