Clinical Analyst

Job Summary

Supporting a growing team, the fully remote Clinical Analyst will provide scientific and clinical analytical support, focusing on the evaluation of drug applications, clinical safety data review, and preparation of scientific reports.

Key responsibilities:

• Analyze and evaluate clinical data from drug applicants and prepare analytical summaries for safety data adequacy
• Assist in the review of proposed drug labeling and provide draft safety data analyses for FDA review
• Draft scientifically sufficient reports and correspondence, clearly communicating clinical safety analyses and findings

Required qualifications:

• PhD/PharmD required
• 5+ years of experience in a similar role
• Expert level R Programming skills required
• Experience with CDISC data standards and their application in clinical trial datasets
• Experience producing a variety of written scientific reports and documents