Clinical Data Scientist, FDA (Jr.)
$90,000–$120,000 year
On-site · Silver Spring, Maryland, United States
Job Summary
Clinical Analyst contractor to provide scientific and clinical analytical support to CDER OND multidisciplinary review teams. Responsibilities include analyzing safety data, reviewing NDAs/BLAs and supplements, preparing analytical reports and recommendations, assisting labeling reviews, drafting safety data analyses, preparing summaries and correspondence, literature review, supporting stakeholder meetings, leading meetings with clinical and statistical reviewers, and coordinating project deliverables. Requires advanced knowledge in health and data sciences, experience with CDISC standards, proficiency in R (mandatory), familiarity with SAS (preferred), and strong clinical safety data analysis skills. Educational requirement: PharmD or PhD in relevant STEM fields. U.S. citizenship or green card required for the government clearance process. Location: Silver Spring, MD (on-site). Salary: $90,000–$120,000 annually. Posting indicates a full-time-equivalent contractor role with emphasis on independent project management within a multidisciplinary FDA-focused environment.
Required Qualifications
- Minimum of 3 years professional experience.
- PharmD or PhD in STEM fields as specified.
- R programming proficiency (mandatory).
- Experience with CDISC SDTM/ADaM and safety datasets.
- Strong analytical and statistical skills.
- Excellent organizational and communication skills.
Desired Qualifications
- PharmD or PhD in the STEM disciplines: bioinformatics, Public Health, Pharmacology, Toxicology, Biology, Biomedical Engineer, biology, biostatistics, epidemiology, health informatics, or pharmaceutical science.
- Strong analytical and statistical skills to assess safety data.
- 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).
- 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.
- Experience in SAS programming (Preferred).
- Machine learning and AI background described as favorable (e.g., predictive modeling techniques).
- Familiarity with FDA regulatory process and/or working experience at FDA.
- Experience in clinical trials and biostatistics concepts.
- Ability to work independently and manage multiple projects.
Additional Requirements
- U.S. citizens or lawful permanent residents required for the security clearance.
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