Regulatory Clinical Data Scientist - Safety Analytics

DRT Strategies; Silver Spring (MD); On-site; USD 90,000 - 120,000; Full time

Job summary

DRT Strategies is seeking a Clinical Analyst contractor to support FDA/CDER safety reviews, data analyses, and reporting. You will evaluate drug safety data, draft analytical summaries, and assist labeling reviews to ensure regulatory compliance.

Responsibilities include performing complex safety analyses with R and SDTM/ADaM datasets, preparing scientific reports, and coordinating with FDA stakeholders and review teams to meet deadlines.

Qualifications

• Minimum 3 years professional experience.
• Proficiency in R for data manipulation, analysis, and visualization.
• Experience with CDISC SDTM/ADaM data standards.
• Strong safety data analysis and statistical skills.
• Excellent written and verbal communication.
• Ability to manage multiple projects independently.

Responsibilities

• Analyze and evaluate submitted drug data and prepare summaries.
• Review NDAs/BLAs and draft analytical reports.
• Prepare safety data analyses for labeling review.
• Draft scientific reports and correspondence for FDA review.
• Lead meetings and collaborate with FDA stakeholders.
• Maintain SharePoint and support project progress.

Skills

R programming

CDISC SDTM/ADaM

Safety data analysis

Statistical methods

Communication skills

MS Office

Education

PharmD or PhD in STEM

Tools

R

SAS

JReview

JMP

Job description

DRT Strategies is seeking a Clinical Analyst contractor to support FDA/CDER safety reviews, data analyses, and reporting. You will evaluate drug safety data, draft analytical summaries, and assist labeling reviews to ensure regulatory compliance.

Responsibilities include performing complex safety analyses with R and SDTM/ADaM datasets, preparing scientific reports, and coordinating with FDA stakeholders and review teams to meet deadlines.