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Clinical Trials Results Analyst (Remote)
ICF's Health Science and Human Services (HS2) Division seeks a ClinicalTrials.gov Results Analyst to support our National Institutes of Health/National Library of Medicine (NIH/NLM) client. The National Institutes of Health, a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research (http://www.nih.gov/). The NLM collects, organizes, and makes available biomedical science information to scientists, health professionals, and the public (http://www.nlm.nih.gov/). This role can be fully remote or hybrid, based in the NIH Bethesda camp.
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journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.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 http://clinicaltrials.gov/ct2/manage-recs/fdaaa
Perform quality assurance/quality control 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, etc.) to facilitate understanding of and adherence to submission requirements
Gain a working knowledge of the ClinicalTrials.gov Basic Results Data Element Definitions (http://prsinfo.clinicaltrials.gov/results_definitions.html) and ClinicalTrials.gov results review criteria (http://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf)
Create new documentation to help responsible parties submit their clinical trial results records
Devise and help implement strategies to improve the quality of submissions
Participate in weekly team meetings with NLM staff to discuss process improvement
PhD (or other degree at the level of a PhD, e.g. PharmD) from an accredited college in a biomedical science and/or mathematics-related discipline (epidemiology, biostatistics, neuroscience, pharmacology, biochemistry, etc.)
1 year experience with standard mathematical concepts and statistics (correlations, trends, significance, etc.)
1 year experience with standard quantitative measures for health studies
Ability to work in the US without sponsorship
Ability to obtain and maintain a public trust
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.
Parametric and non-parametric statistical tests, interpretation of p-value
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
Working at ICF
Working at ICF means applying a passion for meaningful work with intellectual rigor to help solve the leading issues of our day. Smart, compassionate, innovative, committed, ICF employees tackle unprecedented challenges to benefit people, businesses, and governments around the globe. We believe in collaboration, mutual respect, open communication, and opportunity for growth.
We can only solve the world's toughest challenges by building an inclusive workplace that allows everyone to thrive. We are an equal opportunity employer, committed to hiring regardless of any protected characteristic, such as race, ethnicity, national origin, color, sex, gender identity/expression, sexual orientation, religion, age, disability status, or military/veteran status. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO & AA policy.
Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation please email firstname.lastname@example.org and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. Read more about non-discrimination: EEO is the law and Pay Transparency Statement.
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