Clinical Data Scientist, FDA (Sr.)
Tasks
- Analyze safety data from applicants
- Assess labeling safety claims support
- Collaborate to optimize team processes
- Conduct safety data analyses
- Draft labeling safety review support
- Draft scientific correspondence for sponsor submissions
- Lead meetings to present data quality results
- Maintain knowledge of clinical developments
- Manage SharePoint sites
- Prepare analytical summaries and scientific reports
- Review background packages and mock safety datasets
- Review drug applications for safety data adequacy
- Review scientific literature
- Summarize safety data tables figures and listings
- Support clinical review team meetings
- Verify safety data integrity and sufficiency
Perks/Benefits
Skills/Tech-stack
ADaM | Adobe Acrobat | Adverse Event | Adverse event analysis | CDISC | Causal analysis | Correlation Analysis | Event analysis | Excel | Hypothesis Testing | Longitudinal analysis | Machine Learning | Mixed-effects | Mixed-effects models | Neural Networks | Observational Study | Observational Study Design | Pharmacoepidemiology | PowerPoint | R | Random Forest | Real-World Evidence | Regression Analysis | SAS | SDTM | Safety signal detection | SharePoint | Signal Detection | Study design | Survival analysis | Time to Event | Time to event analysis | Word
Education
Regions
Countries
States
Cities
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