FDA Clinical Data Scientist — Regulatory Safety Analytics

drtstrategies; Silver Spring (MD); On-site; USD 90,000 - 120,000; Part time

Job summary

DRT Strategies, Inc. seeks a Clinical Analyst contractor to support CDER OND teams by evaluating safety data, performing analyses, and generating high-quality scientific reports. The role requires advanced health data science knowledge and close collaboration with FDA stakeholders.

Responsibilities include safety data reviews, labeling support, and drafting scientific communications. Strong proficiency in R, CDISC standards, and statistical methods is essential for timely regulatory deliverables.

Qualifications

• Minimum of 3 years professional experience.
• R programming is mandatory for data manipulation, analysis and visualization in regulatory context.
• Experience with CDISC data standards (SDTM/ADaM) and safety dataset structure (e.g., adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, adeg.xpt).
• Understanding of longitudinal and time-to-event analyses for safety data.
• Strong analytical and statistical skills to assess safety data.

Responsibilities

• Clinical Data Analysis and Review of safety data sufficiency and integrity.
• Review NDAs, BLAs, supplements; draft analytical reports and recommendations.
• Prepare safety data analyses for labeling and regulatory submissions.
• Draft scientific reports and correspondence for FDA reviewer use.

Skills

R programming

CDISC SDTM/ADaM

Safety data analysis

Data visualization

SAS programming

FDA regulatory knowledge

MS Office

Education

PharmD or PhD in STEM

Tools

JReview

JMP Clinical

Job description

DRT Strategies, Inc. seeks a Clinical Analyst contractor to support CDER OND teams by evaluating safety data, performing analyses, and generating high-quality scientific reports. The role requires advanced health data science knowledge and close collaboration with FDA stakeholders.

Responsibilities include safety data reviews, labeling support, and drafting scientific communications. Strong proficiency in R, CDISC standards, and statistical methods is essential for timely regulatory deliverables.