Results Analyst

Overview

Black Canyon Consulting (BCC) is searching for a Clinical Trials Data Quality Analyst to support the Clinical Trials.gov. Operated by the National Library of Medicine (NLM), a component of the National Institutes of Health (NIH), Clinical Trials.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journal articles that are reviewed by both scientific colleagues and editors, data submitted to Clinical Trials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.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 Clinical Trials.gov. Information regarding the Clinical Trials.gov database and reporting requirements can be found at (Use the "Apply for this Job" box below)..

• 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 Clinical Trials.gov Basic Results Data Element Definitions  and Clinical Trials.gov results review criteria -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 Clinical Trials.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 with the following concepts:
  Mean, median, least square mean, st.dev, range, interquartile range, confidence intervals, etc
• Experience with:
  Frequency, incidence, proportion, percentage, rate, etc
• Experience with Time to event measures

We attract the best people in the business with our competitive benefits package, including medical, dental, and vision coverage; a 401(k) plan with employer contribution; paid holidays, vacation, and tuition reimbursement.

We offer a competitive salary commensurate with experience and location. The targeted range for this position is $87,000 - $91,000.

If you enjoy being part of a high-performing, professional, technology-focused organization, please apply today!