Biostatistics Research for Clinical Studies – U.S. Dept. of Health & Human Services (HHS)
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:
- Literature research: perform literature research on innovative trial design methodology, such as adaptive trial design and Bayesian trial design, with the goal of identifying appropriate trial design candidates for a clinical trial for the development of novel therapeutics for serious influenza illnesses.
- Simulation study: conduct simulation studies with R and SAS to capture the operating characteristics of candidate novel trial designs, with the goal of identifying the best trial design in terms of trial performance utilities.
- Comparative research: compare the proposed novel design with the conventional designs, with the goal of characterizing the advantages and disadvantages of the novel trial design.
- Data analysis: apply the novel trial design methodology to real clinical trial data to access the feasibility and performance of the novel trial design.
- Provide statistical support: help develop task orders and study protocols to support an integrated summary of safety of pandemic influenza vaccines and adjuvants to be conducted by DCD’s clinical study network
- Technical support for representative clinical trials supported by DCD: actively participate in selected Project Coordination Team (PCT) meetings to provide subject matter expertise related to clinical study design; participate in team communications with FDA, sponsors, CROs, and other partners to ensure progress.
Travel for presentations at conferences/meetings may be required.
Anticipated Appointment Start Date: September 1, 2019
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