Results Analyst

Black Canyon Consulting (BCC) is searching for a Clinical Trials Data Quality Analyst to support the ClinicalTrials.gov. Operated by the National Library of Medicine (NLM), a component of the National Institutes of Health (NIH), ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical research conducted in the United States and around the world. Both registration and results submission are accomplished through the web-based Protocol Registration and Results System (PRS). Responsible parties commonly register trials and submit results prior to a journal publication. Unlike journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.

The successful candidate for this position will be responsible for reviewing results data submissions to ascertain whether they meet minimal review criteria for posting on ClinicalTrials.gov. Information regarding the ClinicalTrials.gov database and reporting requirements can be found at https://clinicaltrials.gov/policy/fdaaa-801-final-rule.

• →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

• 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
• 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

• Must be able to obtain and maintain a Public Trust clearance
• Must reside in and be authorized to work in the United States; candidates in the DMV area preferred
• All work must be performed within the United States

• 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, st.dev, range, interquartile range, confidence intervals, etc
  • Frequency, incidence, proportion, percentage, rate, etc
  • Time to event measures