Job Overview

Summary

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),  Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Epidemiology (OBE), Division of Biostatistics (OB), Vaccine Evaluation Branch (VEB), Rockville, MD.  
Who May Apply:  Open to all United States Citizens.

Duties

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    • Utilize a variety of software systems for statistical analysis, report writing and communications.     
    • Provide authoritative advice to scientists and officials of the agency, other federal government agencies, regulated industry, academia and foreign governments concerning statistical aspects of regulatory submissions.      
    • Conduct original biostatistical research in areas relevant to the program’s mission. 
    • Serve as a specialist in statistical methodology and its applications in the area of preventive vaccines and related biological products. 
    • Collaborate with Divisions in the Center for Biologics Evaluation and Research regarding the evaluation of regulated studies and the conduct of primary research activities. 
    • Perform statistical reviews of IND’s and BLA’s.
    • Provide written analysis and evaluations on results, ,strengths and weakness of methods and data.
    • Prepare written comments to sponsors and applicants to clarify issues and to convey reservations and problems relating to the applications and their supplements. 
    • Report routine and critical issues in the interpretation and application of regulations and policy related to the approval of preventive vaccines and related products involving malaria, varicella zoster and influenza vaccines. 
    • Make presentations at meetings communicating the results of research. 
    • Report routine and critical issues in the interpretation and application of regulations and policy related to the approval of preventive vaccines and related products involving malaria, varicella zoster and influenza vaccines.  Bottom of Form
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Travel Required

  • Not Required

Relocation Authorized

  • No