Clinical Data Scientist, FDA (Mid)
Tasks
- Analyze safety data
- Assess safety data sufficiency and integrity
- Collaborate on project schedules and deliverables
- Conduct safety data analyses
- Draft analytical summaries for FDA review
- Draft safety data summaries for labeling accuracy
- Draft scientific correspondence
- Lead meetings to present data quality results
- Maintain clinical knowledge management
- Manage SharePoint sites and project artifacts
- Prepare background materials for meetings
- Prepare scientific reports
- Review background packages and safety datasets
- Review drug application safety datasets
- Review scientific literature
- Summarize safety tables figures and listings
- Support clinical review teams for stakeholder meetings
- Support drug labeling safety claim review
- Track risks issues and action items
- Verify safety data submitted by applicants
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Adobe Acrobat | Adverse Events | CDISC | Causal analysis | Clinical Safety | Correlation Analysis | Epidemiology | Event analysis | Excel | FDA | Hypothesis Testing | JavaScript | 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 | Statistical Analysis | Study design | Survival analysis | Time to Event | Time to event analysis | Word
Education
Roles
Analyst | Clinical Analyst | Clinical Data Scientist | Data Scientist | Scientist
Regions
Countries
States
Cities
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