Clinical Data Scientist - Regulatory Safety Analytics

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

Job summary

DRT Strategies, Inc. is seeking a Clinical Analyst contractor to provide scientific and clinical analytical support to CDER OND, evaluating drug safety data, performing safety analyses, and preparing high-quality reports for regulatory review.

The role involves collaboration with FDA stakeholders, review of NDAs/BLAs, and drafting safety data analyses for labeling and correspondence. A US government clearance may be required; strong regulatory and data science skills are essential.

Qualifications

• 3+ years of professional experience in clinical safety data analysis
• Proficiency in R for data manipulation, analysis and visualization in regulatory context
• Experience with CDISC SDTM/ADaM data standards and safety datasets

Responsibilities

• Analyze safety data sufficiency and integrity across NDA/BLAs and prepare analytical reports for FDA reviewers
• Review labeling to assess safety claims and support labeling accuracy analyses
• Draft scientifically sound reports and correspondence communicating safety analyses and conclusions

Skills

R programming

CDISC SDTM/ADaM

Safety data analysis

Statistical analysis

MS Office

Education

PharmD or PhD in STEM

Tools

JReview

JMP

JMP Clinical

SAS programming

Job description

DRT Strategies, Inc. is seeking a Clinical Analyst contractor to provide scientific and clinical analytical support to CDER OND, evaluating drug safety data, performing safety analyses, and preparing high-quality reports for regulatory review.

The role involves collaboration with FDA stakeholders, review of NDAs/BLAs, and drafting safety data analyses for labeling and correspondence. A US government clearance may be required; strong regulatory and data science skills are essential.