A complete application package consists of:
If you have questions, send an email to BARDA@orau.org. Please include the reference code for this opportunity in your email.
The Division of Clinical Development (DCD) within the Biomedical Advanced Research and Defense Authority (BARDA) (part of the U.S. Department of Health and Human Services) provides technical support for all the clinical studies funded and sponsored by BARDA, and the application of innovative clinical trial design is critical in meeting the challenges of the advanced development of medical countermeasures for emerging health threats of the US population.
The participant will assist with the innovative clinical trial design development effort. The learning objectives for the participant are: 1) To facilitate research and development of innovative clinical trial designs for medical countermeasures. 2) To gain hands-on experience with the implementation of clinical trials in real-time.
Main activities will include contributing to discussions on developing and applying new methodologies on innovative clinical trial design and analysis, and conducting simulation studies to assess the performance of the proposed trial designs and data analyses. Other opportunities may include providing technical support for DCD projects, assisting in the development of relevant study documents such as clinical study protocols and statistical analysis plans, interacting with program officers, participating in team communications with regulatory authorities and other federal partners, drug developers, academic centers, and Contract Research Organizations, all to ensure progress on the mission of BARDA.
Areas of interest include:
Travel for presentations at conferences/meetings may be required.
Anticipated Appointment Start Date: September 1, 2019
This program, administered by ORAU through its contract with the U.S. Department of Energy (DOE) to manage the Oak Ridge Institute for Science and Education (ORISE), was established through an interagency agreement between DOE and BARDA. The initial appointment is for one year, but may be renewed upon recommendation of BARDA and is contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience, a monthly health insurance stipend supplement, and a travel allowance. Proof of health insurance is required for participation in this program. The appointment is full-time at HHS in the Washington, DC, area. Participants do not become employees of HHS, BARDA, DOE or the program administrator, and there are no employment-related benefits.
While participants will not enter into an employment relationship with BARDA, this appointment requires a pre-appointment check and a full background investigation.
This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR).
The qualified candidate should have a master's or doctoral degree, or be in the late stage of pursuing an advanced degree in statistics or biostatistics.
I have received a master's or doctoral degree, or am in the late stages of completing a master's or doctoral degree.