Overview Global Systems Engineering (GSE), an Intreped Partners Company, is a HUBZone small business that supports the federal government with high-end technical and engineering services. We are responsive to our customers’ needs, which often change. This creates a fast-paced environment where priorities shift and tasks may require short deadlines. GSE is seeking Sr. Scientific Technical Advisors, contingent upon contract award, to be performed hybrid onsite in Washington, DC. Responsibilities Provide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses. Provide advanced services, including but not limited to: data cleaning, data transfer, data quality control, data integration and validation, data analysis and report package preparation, statistical simulation, statistical toolbox for advanced data modelling, tabulation, and visualization. Provide ad hoc statistical support to BARDA projects under the guidance of BARDA statisticians. Direct tasks and lead technical efforts and scientific projects. Act as an SME on scientific subjects. Contribute subject matter expertise to programs with technical or program management expertise. Facilitate meetings as directed. Provide advisory support to BARDA Program Division(s); prepare draft work statements (SOW, SOO, PWS IGCE & Cost Estimates) for solicitations (RFIs, RFPs, SSNs, et al.). Serve as advisor on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals. Participate in Program Coordination Teams (PCTs). Provide assessments, recommendations, and guidance, as well as educational material to PCT and COR, as needed. Participate in strategic discussions with the USG to build new program areas in alignment with BARDA’s mission space. Provide recommendations for project development, portfolio management, and oversight as required. Provide recommendations or advice on development, implementation, and improvement of Total Life Cycle Cost (TLCC) efforts; participate in market research efforts. Analyze protocols, study reports, regulatory documents, presentations, proposals, and related documents, as needed. Additional duties related to programmatic support for MCM may be assigned. Qualifications (Required) Minimum of twelve (12) years of relevant experience with a doctoral degree in biological and/or chemical sciences with relevant postdoctoral experience. Or clinical studies: application of doctoral degrees in medicine or pharmacy or with commensurate experience; advanced degree in computer science, statistics, or related fields; extensive knowledge and experience in clinical trials and epidemiological research; seven (7) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software; extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred; PhD in a life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or a Master’s or Bachelor’s (with commensurate experience) in a physical science field (engineering, physics, computer science, or similar). Or relevant industry experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control positions, with a degree in biology, chemistry, or pharmacy and commensurate experience. Or a bachelor’s degree in chemistry, engineering, or biology with ten (10) years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and TLCC management. Or equivalent* Waiver may be issued by the government if the proposed candidate has a combination of minimum years of industry experience and/or degree in desired discipline along with a minimum of five years (260 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM).

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