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Clinical Trials Results Analyst
The 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/).
Due to COVID 19, this position will be begin remote and eventually will be located in our client's Bethesda, MD office. Work From Home Flexible
- 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
- 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
- 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.
COVID-19 Policy: New or prospective U.S. employees must provide proof of complete vaccination on the date of their commencement of employment. If selected for employment, you will provide proof of your full vaccination status, defined as vaccinated two weeks after receiving the requisite number of doses of a COVID-19 vaccine approved or authorized for emergency use by the FDA.
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.
Maryland Client Office (MD88)