• Perform quality assurance/quality control (QA/QC) reviews of clinical trial results submissions for consistency with review criteria
• Clearly communicate (via record reviews, teleconferences, emails, workshops, etc.) with “responsible parties” (e.g., clinical trial sponsors, principal investigators, statisticians) to facilitate understanding of and adherence to submission requirements
• Gain and use a working knowledge of the ClinicalTrials.gov Basic Results Data Element Definitions (https://clinicaltrials.gov/policy/results-definitions) and ClinicalTrials.gov results review criteria (https://clinicaltrials.gov/submit-studies/prs-help/results-quality-control-review-criteria)
• Create new documentation to help responsible parties submit their clinical trial results records in accordance with established review criteria
• Devise and help implement strategies to improve the quality of submissions
• Support database management activities
• Serve as liaison between data providers (e.g., NIH, industry, universities, and other organizations) and ClinicalTrials.gov
• Participate in weekly team meetings with NLM staff to discuss process improvement

Basic Qualifications

• Master’s degree in biomedical science and/or mathematics-related discipline (epidemiology, biostatistics, neuroscience, biochemistry, etc.)
• 3+ years’ experience with standard mathematical concepts and statistics (correlations, trends, significance, etc.)
• 1+ year experience with standard quantitative measures for health studies

Preferred Skills/Experience

• Ph.D. in biomedical science and/or mathematics-related discipline (epidemiology, biostatistics, neuroscience, biochemistry, etc.)
• Background knowledge relevant to understanding and interpreting clinical trial data and statistics
• 1+ year experience with analysis and reporting of clinical trial data
• Strong critical thinking, analysis, and problem-solving skills
• Ability to critically appraise clinical trial design and methodology and to identify internal inconsistencies in clinical trial data reporting
• Experience (via coursework and/or job duties) working with and interpreting the following concepts:
• Mean, median, least square mean, standard deviation, range, inter-quartile range, confidence intervals, etc.
• Frequency, incidence, proportion, percentage, rate, etc.
• Time-to-event measures
• Parametric and non-parametric statistical tests, interpretation of p-value

Professional Skills

• Ability to work within a team environment and contribute to consensus-based decision making
• Ability to identify, analyze, and solve problems creatively and independently
• Ability to handle multiple tasks simultaneously and shift priorities as directed
• Ability to work efficiently with team members in a fast-paced environment
• Excellent oral and written communication skills
• Excellent interpersonal skills and ability to work with people at every level
• General computer skills with a proficiency in MS Word, Outlook, Excel, and PowerPoint

Clearance and Location Requirements

• Must be able to obtain and maintain a Public Trust clearance
• Must be located within 40 miles of the NIH Bethesda campus (or willing to relocate); this is an on-site position
• Must be authorized to work in the United States