Support services will include conducting clinical research studies with experimental medical products under the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP). All of the work to support this research must be performed in accordance with the Federal, Department of Defense (DoD), and Command laws, regulations, and policies. Clinical research studies require production of experimental products, conduct of research studies, laboratory analysis of samples, analysis of resulting data, and submission of study findings.
- The Contractor shall provide statistics and biostatistics leadership for clinical trials and is directly responsible for the statistical integrity, adequacy, and accuracy of the studies.
- The Contractor shall collaborate in the preparation and review of clinical assessments, provide strategic input into development plan, review all project protocols, author protocol statistical analysis sections, and generate study randomizations.
- This includes, but is not limited to, providing sound strategic, statistical and scientific input on project objectives, experimental design, and data analysis to meet CTC needs and FDA statistical and scientific requirements.
- Contractor shall assume leadership for the Biostatistics activities related to portions of specific project(s), author statistical analysis results in reports, and provide support for publications consistent with priorities and timelines.
Required Knowledge, Skills, and Abilities: Preferred knowledge of clinical research procedures; excellent interpersonal and computer skills; ability to communicate effectively and to work with individuals of all levels. The candidate should be well-organized; ability to follow detailed instructions; ability to handle multiple tasks; ability to meet deadlines of projects; ability to facilitate communication among supervisors, team members, and peers.
Minimum Education/Training Requirements: Bachelor’s degree in Statistics; Master's degree in Statistics strongly preferred
Minimum Experience: 4 to 6 years of related experience.