Scientific Technical Advisors (Contingent)

Description

Global Systems Engineering (GSE), an Intreped Partners Company, is a HUBZone small business that supports the federal government with a variety of 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 Scientific Technical Advisors, contingent upon contract award, to be performed in a hybrid onsite setting in Washington, DC.

Candidate MUST:

Be a US. Citizen or a Green Card Holder with the ability to obtain a Public Trust Clearance

Be located w/in 50 miles of the location for hybrid/onsite work.

Key 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 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
• In addition, this position will provide ad hoc statistical support to BARDA projects under the guidance of BARDA statisticians.
• Directs tasks and leads technical efforts and scientific projects. Acts as an SME on scientific subjects. Contributes subject matter expertise to programs with technical or program management expertise. Facilitates meetings as directed.
• Provide advisory support to BARDA Program Division(s); Prepare draft work statements (SOW, SOO, PWS IGCE & Cost Estimates) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al].
• Serve as advisor(s) 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, level portfolio management, and oversight as required.
• Provide recommendations or advice on development, implement, and consciously improve 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.

Required Qualifications:

Minimum of five (5) years of relevant industry experience with a Bachelor’s degree (preferred) in biological and/or chemical sciences and/or relevant experience.

Or

Postgraduate degree(s) in medicine or pharmacy, or with commensurate experience , bachelor's degree in computer science, Statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research, including three (3) 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. Bachelor's degree (graduate preferred) in an appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or

Bachelors (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar)

Or

Relevant industry experience (listed) 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 five (5) 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 Total Life Cycle Cost (TLCC) management.

Or equivalent*

Waiver maybe issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG with a minimum of five years (52 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM).