Manager Biostatistics (Study Lead Statistician)
Tasks
- Assist development and implementation of AI technology to streamline statistical work
- Communicate study findings analysis and insights to stakeholders
- Define signal detection threshold
- Develop randomization specifications and statistical analysis plans
- Drive process improvement initiatives
- Execute clinical trials according to protocol
- Maintain statistics sections of the TMF
- Manage resources to meet priorities and ensure timely deliverables
- Oversee statistical contributions to key design elements and documentation
- Perform risk assessments and ensure quality data collection
- Produce tables figures and listings flash memos and clinical study reports
- Provide statistical contributions review and quality control for study design documents
- Review deliverables from external suppliers for quality
- Serve as GBS lead for clinical study team leadership
- Support review of policies SOPs and controlled documents
Perks/Benefits
- N/A
Skills/Tech-stack
Analysis Plans | Biostatistics | Clinical Trial Design | Clinical Trial Simulation | Clinical study | Clinical study report | Clinical trial | Clinical trials | Data analytics | Drug development | Electronic Health Records | Health Records | Life cycle drug development | Machine Learning | Randomization | Real-World Data | Real-world data analytics | Risk Assessment | Signal Detection | Statistical Analysis | Statistical analysis plans | TMF | Tables Figures and Listings | Trial design | Trial simulation
Education
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