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.  General SME Responsibilities: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), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.Participate as subject matter experts on Program Coordination Teams (PCTs).Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise. Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work. Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations. Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space. Provide recommendations for project development level portfolio management and oversight as required. Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.Senior 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).Supervise less experienced Statistics Subject Matter Experts.Serve as the primary interface with BARDA and Industry Senior Leadership on statistics matters.Coordinate with program managers, scientists, and other subject matter experts as required.Participate in the design, analysis, and reporting of research studies.Provides consultation to investigators and researchers on experimental design, and statistical research approaches, requirements, and scientific standard.Work with investigators to formalize analysis plans and reporting specifications.Advise BARDA leadership and industry partners as to the choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.Plan and document computer data file structureDevelop, program, manage, and maintains complex statistical databases.Performs or supervises data entry.Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for research data.Advise and assist in the development of inferences and conclusions, as appropriate.Develop enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodology.Prepare a variety of comprehensive statistical reports according to presentation requirements.Participates in manuscript preparation to include preparation of data summaries and statistical results for publication.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.
