FDA Clinical Data Scientist - Regulatory Safety Analytics

DRT Strategies; Silver Spring (MD); On-site; USD 95,000 - 125,000; Full time

Job summary

DRT Strategies is recruiting a Clinical Analyst contractor to support CDER OND safety data analyses, reporting, and labeling review. The role focuses on evaluating clinical safety data, generating analytical reports, and communicating findings to FDA reviewers.

The position requires a PhD or PharmD with at least 3 years of professional experience and strong R programming skills, plus familiarity with CDISC SDTM/ADaM standards and safety datasets.

Qualifications

• PhD or PharmD with minimum of 3 years professional experience.
• Technical proficiency in R for data manipulation, analysis, and visualization in a clinical/regulatory context.
• Experience with CDISC data standards (SDTM/ADaM) and safety dataset structure (adsl.xpt, adae.xpt, etc).
• Understanding of safety data analysis methods (longitudinal, time-to-event, causal/correlation).
• Strong analytical and statistical skills to assess safety data.
• Excellent organizational and communication skills, able to manage multiple projects.

Responsibilities

• Analyze and evaluate submitted data from applicants seeking approval to market new drugs and prepare analytical summaries.
• Review NDAs, BLAs, supplements, and amendments and prepare analytical reports and recommendations.
• Review safety data and prepare reports and summaries for FDA review teams.
• Draft scientific reports communicating clinical safety analyses and conclusions.
• Lead meetings with clinical reviewers and coordinate across teams.

Skills

R programming

Data analysis

Statistical analysis

Regulatory science

Education

PhD or PharmD

Tools

CDISC SDTM/ADaM

SAS/JReview/JMP

Job description

DRT Strategies is recruiting a Clinical Analyst contractor to support CDER OND safety data analyses, reporting, and labeling review. The role focuses on evaluating clinical safety data, generating analytical reports, and communicating findings to FDA reviewers.

The position requires a PhD or PharmD with at least 3 years of professional experience and strong R programming skills, plus familiarity with CDISC SDTM/ADaM standards and safety datasets.