Clinical Data Scientist, FDA (Sr.)
$100,000–$135,000 year
On-site · Silver Spring, Maryland, United States
Job Summary
Clinical Data Scientist to provide scientific and clinical analytical support to CDER OND multi-disciplinary review teams, evaluating safety data from drug applications, reviewing labeling for safety claims, drafting analytical reports and scientific communications, and supporting literature reviews and stakeholder engagements. The role involves reviewing NDAs/BLAs and amendments, performing safety data analyses, generating high-quality reports, and collaborating with FDA staff to optimize processes and deliverables. Requires strong programming in R, experience with CDISC data standards, and a background in pharmacovigilance/regulatory science. Salary range $100k-$135k with potential collaboration across FDA stakeholders and formal review interactions.
Required Qualifications
- Minimum of 3 years’ professional experience
- Technical proficiency in R (mandatory) for data manipulation, analysis, and visualization in clinical or regulatory context
- Experience with CDISC data standards (SDTM, ADaM) and safety dataset structure (adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, adeg.xpt)
- Understanding of safety review elements (trial design, demographics, exposure, SAE, TEAE, lab tests, vital signs) and safety data analyses
- Strong analytical and statistical skills for safety data assessment
- Excellent organizational and communication skills
- Ability to independently manage multiple projects with shifting priorities
- MS Office Suite proficiency (PowerPoint, Word, Excel) and Acrobat
- Ability to work in multidisciplinary teams
- U.S. government Public Trust clearance ability; U.S. citizenship or lawful permanent residency required
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