Clinical Analyst

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess and evaluate submitted applicant information for new drug marketing applications, creating analytical summaries regarding the adequacy of safety data.

• Review New Drug Applications (NDAs), Biologics License Applications (BLAs), supplements, and amendments; draft analytical reports and recommendations for consideration by FDA reviewers.

• Integrate clinical safety data review summaries into comprehensive multidisciplinary evaluations.

• Aid in the review of proposed drug labeling to determine if safety claims are truthful and sufficiently supported.

• Provide preliminary analyses of safety data concerning labeling accuracy and completeness for FDA staff review.

• Compose scientifically robust reports that communicate clinical safety analyses and conclusions.

• Generate draft correspondence highlighting inadequately presented facts and information in sponsor submissions.

• Create clear summaries of clinical safety data tables, figures, and listings for FDA review teams.

• Examine scientific literature and stay informed about current clinical advancements and findings.

• Assist in the preparation of background materials for seminars, conferences, and industry meetings.

• Support clinical review teams in their preparations for meetings with drug company representatives, advisory committees, and external scientific organizations.

⛳️ Requirements

• A PhD or PharmD is required.

• A minimum of 5 years of experience in a comparable role.

• Advanced R programming skills are essential.

• Experience in applying clinical safety data analytical skills and synthesizing clinical and scientific evidence for risk assessments.

• Familiarity with CDISC data standards, including SDTM and ADaM, and their application in organizing and analyzing clinical trial datasets.

• Proven ability in producing written scientific reports and documents.

• Knowledge of FDA regulations, policies, and procedures related to safe drugs and biologics, including the review processes for NDAs and BLAs.

• A statistical background, including biostatistical methods used in clinical trial design, analysis, and interpretation, such as survival analysis, mixed-effects models, and hypothesis testing.

• Experience with machine learning and AI, including knowledge of predictive modeling techniques.

• Background in epidemiology, including observational study design, real-world evidence, pharmacoepidemiology, or population-level safety-surveillance methods.

• Must be a US Citizen or a current Green Card holder.

• Must successfully complete a comprehensive background check, which includes criminal history, education verification, professional certification verification, previous employment verification, and credit history.

• Public Trust background investigation requiring fingerprinting.

🏝️ Benefits

• Full-time W2 employment.

• Commitment to equal-opportunity employment.

• Participation in E-Verify.

• Support for Public Trust background investigations, including fingerprinting.