Programmatic Technical Advisor (Mid-Level)

• Provide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses.
• 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 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 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 advise 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 maybe assigned

• 8+ years of relevant industry experience.
• Graduate or advanced degree in biological and/or chemical sciences and/or relevant postdoctoral experience.

OR

• clinical studies: application of an advanced degree(s) in medicine or pharmacy or with commensurate experience(s).
• Master's degree in computer science, Statistics, or related fields.

OR

• 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.
• Advanced degree in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Master’s (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

• 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

• Degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management.
• Ability to obtain and maintain a NACI Background Check.

Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred.

Culmen International is committed to enhancing international safety and security, 
strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over 150 countries, Culmen supports our clients to accomplish critical missions in challenging environments.

• Exceptional Medical/Dental/Vision coverage with 100% of the premiums paid by the company for all eligible employees and their eligible dependents (including same or opposite sex domestic partners)
• 401k – Vested immediately and 4% match
• Life insurance and disability paid by the company
• AFLAC Available
• Opportunities for Training and Continuing Education
• 12 Paid Holidays

To learn more about Culmen International, please visit www.culmen.com

At Culmen International, we are committed to creating and sustaining a workplace that upholds the principles of Equal Employment Opportunity (EEO). We believe in the importance of fair treatment and equal access to opportunities for all employees and applicants.  Our commitment to these principles is unwavering across all our operations worldwide.