Senior Manager R&D Quality Analytics & Portfolio Insights
Tasks
- Analyze adverse event reporting
- Build predictive risk models
- Conduct source to report reconciliation
- Coordinate analytics workstreams from framing to monitoring
- Create executive visualizations and risk summaries
- Detect anomalies in clinical safety data
- Develop analytical dashboards and workflows
- Develop analytics for GLP and GCLP oversight
- Develop analytics for GVP safety oversight
- Develop quality indicators and thresholds
- Develop statistical monitoring methods
- Ensure model validation and testing
- Identify emerging quality risks
- Implement SQL R and Python analytics
- Maintain governed intended use and data lineage
- Perform cross study risk analyses
- Perform data profiling and mapping
- Perform root cause analysis
- Support data informed audit planning
- Support portfolio quality surveillance
Perks/Benefits
- N/A
Skills/Tech-stack
APIs | Access Controls | Anomaly Detection | By Design | Change Management | Cloud Computing | Data Integrity | Data Lineage | Data Mapping | Data Modeling | Data Transformation | Data Warehousing | Data cleaning | Data profiling | ELT | ETL | Explainability | Forecasting | GCLP | GCP | GLP | GVP | Git | Language Processing | Machine Learning | Natural Language | Natural Language Processing | Performance Monitoring | Power BI | Predictive Modeling | Python | Quality by Design | Quality management | R | Report Reconciliation | Risk Management | Risk-Based Quality Management | Risk-based | Risk-based quality | SQL | Source to Report Reconciliation | Statistics | Validation | Version control
Education
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