Overview Leidos is seeking Mid-level Scientific Technical Advisors, contingent upon contract award, to be performed hybrid onsite in Washington, DC. Responsibilities Provide advance services including but not limited to: Data cleaning; Data transfers; 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, etc.). Serve as advisor(s) on Technical Evaluation Panels (TEPs) including white papers/market research abstracts, technical proposals, and budget proposals. Participate on Program Coordination Teams (PCTs). Provide assessments, recommendations, and guidance as well as educational material to PCT and COR, as needed. Participate 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 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 Candidates must demonstrate experience in: understanding 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 technique, sterile manufacturing/filling and sterile facilities (sterile gowning). Provide guidance and recommendations on key issues related to the area(s) identified above. Mid-Level Programmatic / Technical Advisor Qualifications: Advanced degree in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Master’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; application of degree in biology, chemistry, or pharmacy with commensurate experience. Or a bachelor’s degree in chemistry, engineering, or biology including eight (8) 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. Minimum of eight (8) years of relevant industry experience with graduate or advanced degree in biological and/or chemical sciences and/or relevant postdoctoral experience, or clinical studies: application of an advanced degree in medicine or pharmacy or with commensurate experience; master's degree in computer science, statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research including five (5) 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. 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 three years (156 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM). PHHS Come break things (in a good way). Then build them smarter. We're the tech company everyone calls when things get weird. We don't wear capes (they're a safety hazard), but we do solve high-stakes problems with code, caffeine, and a healthy disregard for "how it's always been done." Pay Range: $104,650.00 - $189,175.00 The Leidos pay range for this job level is a general guideline only and not a guaranteed offer. Additional factors considered in extending an offer include responsibilities, education, experience, knowledge, skills and abilities, internal equity, market data, applicable bargaining agreement (if any), or other law.

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