Clinical Data Scientist, FDA (Mid)
$95,000–$125,000 year
On-site · Silver Spring, Maryland, United States
Job Summary
Contractor Clinical Analyst supports CDER OND, analyzes safety data from NDAs/BLAs, prepares analytic reports, reviews labeling for safety claims, drafts scientific reports, conducts literature review, and supports meetings with drug company representatives, advisory committees, and external scientific bodies. The role interacts with FDA stakeholders and requires advanced knowledge in health and data sciences to support risk determinations in regulatory review. Responsibilities include clinical data analysis and review, labeling review support, scientific correspondence and reporting, literature review and knowledge management, stakeholder support, lead meetings with clinical and statistical reviewers, collaboration with CDER OND staff to optimize processes, and management of data quality assessments and safety data analyses using R and CDISC standards (SDTM/ADaM). Preferred experience includes SAS, JMP, and ML/AI applications in safety evaluation. Education & Training emphasizes PhD/PharmD or equivalent degrees; U.S. government Public Trust clearance may be required. Salary range $95,000-$125,000; location is Silver Spring, MD on-site.
Required Qualifications
- PhD or PharmD with minimum of 3 years professional experience.
- Technical proficiency in programming languages- R (mandatory) with demonstrated experience using R for data manipulation, analysis, and visualization in a clinical or regulatory research context.
- R programming – ability to troubleshoot errors in R.
- Experience with CDISC data standards (including SDTM and ADaM) and safety dataset structure (e.g., adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, and adeg.xpt)
- Understands data analytical methods (e.g., longitudinal analysis, time-to-event analyses, and causal/correlation analyses) for conducting safety data analyses (tables and figures)
- Understands safety review elements including trial design, demographics, exposure, death, discontinuation, dose modification, SAE, TEAE, FMQ, AESI, laboratory tests, and vital signs.
- Working knowledge of safety analysis methods, including the evaluation of adverse event data, safety signal detection, and the preparation of standardized safety tables and figures.
- Strong analytical and statistical skills to assess safety data.
- Excellent organizational, time management, verbal and written communication skills.
- Ability to independently manage a variety of projects with frequent interruptions and shifting priorities.
- Ability to organize a continuous flow of work in a timely manner and meet mandatory deadlines.
- Computer skills: MS Office Suite (particularly PowerPoint, Word, Excel), Adobe Acrobat.
- Ability to work independently within a multidisciplinary team.
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