Full-Time BARDA Senior Statistics Subject Matter Expert
BryceTech is hiring a remote Full-Time BARDA Senior Statistics Subject Matter Expert. The career level for this job opening is Expert and is accepting Washington, DC based applicants remotely. Read complete job description before applying.
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Background: In 2006, the Biomedical Advanced Research and Development Authority (BARDA) was established to support vaccine, therapeutic, diagnostic, and technology development during public health emergencies. BARDA's success includes FDA approvals/licenses/clearances, COVID-19 product support, and partnerships. This success relies on public-private partnerships that accelerate medical countermeasure (MCM) development.
General SME Responsibilities: Support BARDA Program Office(s) as a subject matter expert in Chemical, Radiological/Nuclear, Burn/Blast, or Biological Threats (viral/bacterial), Influenza and Emerging Infectious Diseases. Research, development, manufacture, and regulatory approval of MCMs (diagnostics, devices, vaccines, therapeutics). Desired experience includes: medicinal chemistry, preclinical development, advanced clinical development, analytical testing, quality control, clinical/regulatory policy, and manufacturing. Experience in process development, scale-up, optimization, device development/manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology, and plastic consumable design/manufacturing. Provide guidance, recommendations, and advice on technical evaluation panels (TEPs), program coordination teams (PCTs), and expert assessments to PCTs and CORs. Provide subject matter expertise to federal staff for cost estimation, review/comment on protocols, reports, regulatory documents, proposals, and related documents.
Senior Statistics Subject Matter Expert Specific Responsibilities: Provide subject matter expertise in innovative statistical thinking & methods to enhance MCM development. Standardize statistical processes/methodologies across therapeutic areas, guide/monitor sponsored research with CROs, supervise less experienced Statisticians, serve as the primary interface with BARDA/Industry leadership, coordinate with program managers, scientists, and subject matter experts, and participate in study design, analysis, and reporting.
Provide consultation to investigators on experimental design, statistical approaches/requirements/standards, formalize analysis plans/reporting specifications, and advise BARDA/industry partners on statistical analysis strategies, measurement reliability, and model identifiability. Plan/document data file structure, develop/program/manage complex statistical databases, use advanced statistical software, analyze/interpret research data. Advise on inferences/conclusions and develop enhancements to statistical software.
Additional Responsibilities: Prepare comprehensive statistical reports, participate in manuscript preparation, provide program/policy support for clinical evidence/human subject protection, conduct epidemiologic/real-world analyses, facilitate stakeholder collaboration, support data structure/methods for rapid data collection/analysis. Provide expert consultation and support to stakeholders, facilitate discussions with internal/external stakeholders, and develop/evaluate strategies, guidelines, and standards.
Requirements: 15+ years industry experience. Advanced degree in Statistics or related field, 10+ years MCM development experience. Strong programming experience (SAS, R, Python) and proficiency with data analytic platforms (MS Excel, JMP). Must be skilled in medical countermeasure development, animal model development, in vitro assay development, and GLP regulations. Strong communication and interpersonal skills.