Clinical Data Scientist, FDA (Jr.)
Tasks
- Analyze clinical safety data
- Conduct safety data analyses
- Draft labeling safety accuracy assessments
- Draft scientific correspondence for FDA review
- Maintain clinical knowledge management
- Manage project schedules and deliverables
- Optimize team processes and reporting
- Organize and update SharePoint sites
- Perform scientific literature reviews
- Prepare analytical summaries and scientific reports
- Review drug application safety data
- Summarize clinical safety tables figures and listings
- Support stakeholder meetings and presentations
- Verify safety data integrity
Perks/Benefits
Skills/Tech-stack
ADaM | Adobe Acrobat | Adverse Event | Adverse event analysis | Biostatistics | CDISC | Causal Inference | Classification Models | Clinical Trial Design | Clinical trial | Correlation Analysis | Epidemiology | Event analysis | FDA Regulatory | FDA regulatory process | Hypothesis Testing | JMP | JMP Clinical | JReview | Longitudinal analysis | Machine Learning | Microsoft Excel | Microsoft PowerPoint | Microsoft Word | Mixed-effects | Mixed-effects models | Neural Networks | Observational Study | Observational Study Design | Pharmacoepidemiology | Pharmacoepidemiology surveillance | R | Random Forest | Real-World Evidence | Regression Analysis | Regulatory process | SAS | SDTM | Safety signal detection | Series analysis | SharePoint | Signal Detection | Study design | Survival analysis | Time Series | Time Series Analysis | Trial design
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD | PharmD
Roles
Analyst | Clinical Analyst | Clinical Data Scientist | Data Scientist | Scientist
Regions
Countries
States
Cities
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