Must be a US Citizen or Green Card Holder
W2 with full benefit

Some travel may be required
Offer contingent on ability to successfully pass a background check and drug screen

Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Sr. Scientific Program Manager to work onsite with the National Institutes of Health in Bethesda, MD.

This is a long-term position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com

The US base salary range for this full-time position is $50-$95/hr benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

Scope:

Under this Task Order, the Contractor(s) shall provide services in support of the overall functions of the Translational Science Team (TST).

Technical Requirements:

Provide accountability for the scientific deliverables and contributions of the Vaccine Research Centers (VRC) Translational Science Team.

Oversee essential team functions, ensuring that: All scientific objectives of VRC clinical trials are met; Clinical trial data is accurately analyzed and project timelines established by VRC leadership are met.

VRC clinical trial data is managed according to best practices and securely archived in digital data management platforms.

Clinical trial data is accurately communicated in a timely fashion to the public, VRC leadership and internal teams, and external stakeholders including academia, government and industry partners.

Serve as the Scientific Review Chair in the development of VRC clinical trial protocols to provide subject matter expertise and scientific oversight.

Perform complex data analysis on first in-human clinical trial data, involving multiple procedures and a variety of technical approaches, including statistical and multivariant modeling.

Process, analyze and interpret large, complex primary clinical trial datasets.

Develop novel methodologies for analyzing immunological and pharmacokinetic data from both vaccine and monoclonal antibody clinical trials.

Develop protocol scientific objectives and analytical laboratory testing plans for first-in-human clinical trials testing vaccines and therapeutics for infectious diseases.

Prepare high level executive summaries of data for senior leadership to use in key decision Making.

Prepare complex scientific reports for publication in top-tier peer reviewed scientific journals.

Provide expert advice and consultation related to clinical trials to laboratory and research staff.

Provide insight to VRC Primary Investigators, scientists, and research staff on clinical and immune assessments assays.

Author descriptions of complex immune response data and clinical trial results for regulatory reports, product licensees and internal and external stakeholders.

Provide peer review as a scientific expert for original scientific manuscripts.

Effectively collect, organize, store, protect, and process data; ensure useability of datasets.

Lead and manage secure storage of clinical data on digital data management platforms according to industry standards and best practices.

Provide raw data to collaborators and post to online repositories upon approved requests/as required by NIH data sharing standards.

Assist FTL with integration of new team members by training junior team members to follow internal work instructions and standard operating procedures (SOPs) pertaining to data analysis and data management.

Provide guidance related to clinical trials to laboratory staff.

Participate in planning of new projects; provide expert advice and consultation on development of clinical trial protocols, analytical laboratory testing plans, and statistical analysis plans.

Write and review technical protocols, work instructions, and reports documenting analytical development studies.

Travel and Training Requirements:

Travel may be required, at the discretion of the Task Leader.

All Travel must be approved in writing by the Contracting Officer

All travel and training, if approved by the COR and the Contracting Officer, will be funded through a subsequent modification. Please do not include these costs in your task order proposal.

Other Requirements:

This requirement is for a Full Time Equivalent employee, consisting of 1920 hours (excluding Federal Holidays)

Work will be performed up to 40 hours per week during normal business hours, Monday-Friday, excluding Federal holidays.

However, work can run past business hours and flexibility will be needed, and the contractor will be responsible for scheduling.

Telework may be authorized if approved by the Task Leader, COR, and the Contracting Officer.

Specific Qualifications:

Ph.D. in Biomedical Science, Biology or a related discipline.

Minimum of two (2) years of related experience; demonstrates knowledge of a broad range of scientific and technical areas.

Experience in understanding and analyzing complex biomedical information and research findings.

Ability to maintain and develop sources of information to gather data and transmit findings in areas of biomedical science.

Skill in designing and creating documents, using desktop publishing software and office tools.

Skill in using medical/scientific computer databases to search and collect information.

Knowledge of graphing and reference and bibliographic software.

Equal Opportunity/Affirmative Action:
We are committed to hiring and retaining a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, marital status, age, national origin, veteran status, disability status, or any other protected class. EEO/AA/MFDV

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