Note: The job is a remote job and is open to candidates in USA. Spatial Front, Inc. is a workplace-recognized company supporting multidisciplinary regulatory review teams. The Clinical Analyst provides scientific and clinical analytical support by evaluating drug applications, reviewing clinical safety data and labeling, preparing scientific reports, and supporting FDA review activities.
Responsibilities
- Analyze and evaluate submitted data from applicants seeking permission to market new drugs for general use and prepare analytical summaries on the adequacy of safety data provided
- Review NDAs, BLAs, supplements, and amendments; prepare draft analytical reports and recommendations for FDA reviewer consideration
- Incorporate summaries from clinical safety data reviews as part of integrated multi-disciplinary assessments
- Assist in the review of proposed drug labeling to assess whether safety claims are truthful and adequately supported
- Provide draft safety data analyses on labeling accuracy and completeness for review by FDA staff
- Draft scientifically sufficient reports of findings that clearly communicate clinical safety analyses and conclusions
- Prepare draft correspondence identifying facts and information inadequately presented in sponsor submissions, for FDA reviewer finalization and issuance
- Prepare clear summaries of clinical safety data tables, figures and listings for FDA review team use
- Review scientific literature and maintain awareness of current clinical developments and evolving findings in relevant therapeutic areas
- Support preparation of background materials for seminars, conferences, and industry meetings
- Support clinical review teams in preparing for meetings with drug company representatives, advisory committees, and external scientific bodies
Skills
- PhD/PharmD required
- 5+ years of experience in a similar role
- Expert level R Programming skills required
- Experience in applying clinical safety data analytical skills, including the ability to synthesize clinical and scientific evidence to inform risk assessments
- Experience with CDISC data standards (including SDTM and ADaM) and their application in the organization and analysis of clinical trial datasets
- Experience producing a variety of written scientific reports and documents
- US Citizen and/or Current Green Card Holder
- Familiarity with FDA regulations, policies, and procedures pertaining to safe drugs and biologics, including NDA, and BLA review processes
- Statistical background, including experience with biostatistical methods commonly applied in clinical trial design, analysis, and interpretation (e.g., survival analysis, mixed-effects models, hypothesis testing)
- Machine learning and AI background, including familiarity with predictive modeling techniques
- Epidemiological background, including experience with observational study design, real-world evidence, pharmacoepidemiology, or population-level safety surveillance methods
Company Overview