Clinical Data Scientist, FDA (Mid)
Tasks
- Conduct safety data analyses
- Conduct scientific literature review
- Draft safety analysis for labeling accuracy and completeness
- Draft scientific reports and conclusions
- Generate scientific safety reports
- Lead meetings with clinical and statistical reviewers
- Maintain SharePoint sites
- Maintain clinical developments knowledge
- Manage project progress risks issues and action items
- Optimize team processes and deliverables
- Prepare background materials for seminars and conferences
- Prepare scientific correspondence for FDA
- Review background packages and mock safety datasets
- Review proposed drug labeling for supported safety claims
- Review safety data sufficiency and integrity
- Summarize clinical safety data tables figures and listings
- Support clinical review teams for stakeholder meetings
- Support project deliverables
- Verify applicant safety data
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Adobe Acrobat | Adverse Event | Adverse event analysis | CDISC | Causal analysis | Classification Models | Clinical Safety | Correlation Analysis | Epidemiology | Event analysis | Excel | Hypothesis Testing | Longitudinal analysis | MS Office | Machine Learning | Mixed-effects | Mixed-effects models | Neural Networks | Pharmacoepidemiology | PowerPoint | Predictive Modeling | R | Random Forest | Real-World Evidence | Regression Models | SAS | SDTM | Safety signal detection | Series analysis | SharePoint | Signal Detection | Survival analysis | Time Series | Time Series Analysis | Word
Education
Roles
Analyst | Clinical Analyst | Clinical Data Scientist | Data Scientist | Scientist
Regions
Countries
States
Cities
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