BARDA Statistics Subject Matter Expert

Background. In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.  Subject Matter Expert Responsibilities – General.Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats) as well as the research, development, manufacture and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics, preventives, and therapeutics.Provide guidance and recommendations on key issues related to the area(s) identified above.Review study protocols, study reports, regulatory documents, presentations, proposals, and related documents.Provide senior-level briefing(s) to ASPR/BARDA as required.Prepare regular reports to ASPR/BARDA management on various technical issues identified as required.Provide recommendations for project development level portfolio management and oversight as required.Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.Participate in Market Research efforts.Statistics Subject Matter Expert Specific Responsibilities.Provide subject matter expertise in innovative statistical thinking and methods to help drive the enhanced quantitative Medical Countermeasures development paradigm within BARDA.Standardize statistical processes and methodologies across therapeutic areas.Provide support to BARDA’s development networks guiding and monitoring sponsored research with Contract Research Organizations (CROs).Provide program and policy support for clinical evidence and human subject protection, conduct epidemiological or real-world evidence analyses, facilitate collaboration and outreach with hospitals and other external stakeholders, or support the assessment and development of data structures and other methods for rapid data collection and analysis.Provide expert consultation and support to the BARDA stakeholders, as needed.Provide statistical expert scientific, technical, and regulatory support and direction to colleagues in response to questions related to the access and use of clinical evidence.Facilitate discussions with internal and external stakeholders to facilitate rapid collaboration.Develop and conduct assessments on the impact of emerging laws, regulations, and standards for medical device and radiological health product manufacturers, importers, and facilities that use these products. May also oversee, monitor, and evaluate international standards.Assesses emerging, complex, and precedent-setting issues that impact programs, analysis, and policies.Review relevant data for accuracy, precision, and reliability and makes recommendation on whether the data provided are sufficient for analysis.Review program, policy, and analysis protocols and develop solutions for approaches to testing, analysis, program, or policy support.Develop strategies for improving one or more of the following: clinical or real-world evidence studies, epidemiologic analysis, data infrastructure methodologies, opportunities to work with other center officials to assess public safety signals, or medical device partnership opportunities.Write and evaluate strategies, guidance documents, guidelines, and standards to improve evaluation, analysis, or program execution. Conduct discussions with industry engineers, scientists, and management officials.