BARDA Senior Statistics Subject Matter Expert

Company Description

BryceTech. BryceTech has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision making. Bryce cultivates a culture of engagement and partnership with our clients. Bryce Space and Technology is an Equal Opportunity Employer.

BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.

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.  

Job Description

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.

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 structure
• Develop, 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