Statistician - Department of Orthopaedic Surgery and Sports Medicine
Tasks
- Calculate sample size
- Collaborate with data managers and clinical teams
- Create interim analysis plans
- Design study protocols
- Develop randomization schemes
- Develop statistical analysis plans
- Ensure GDPR compliance
- Ensure HIPAA compliance
- Ensure IRB compliance
- Maintain and optimize electronic data capture platforms
- Maintain statistical report sections
- Mentor junior staff in statistical best practices
- Perform data quality assurance audits
- Perform statistical analyses on clinical trial data
- Prepare regulatory submissions statistical sections
- Produce data summaries dashboards and reports
- Resolve data queries
- Validate statistical methods for reproducibility
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR Part 11 | Adaptive Designs | Analysis Plan | Bayesian Methods | CFR Part 11 | Data Capture | Data Quality | Data Query | Data Query Resolution | Data Visualization | Data quality assurance | EMA | Electronic Data | Electronic data capture | Electronic documentation | FDA | FDA 21 CFR | FDA 21 CFR Part 11 | GDPR | HIPAA | ICH GCP | IRB | Interim analysis | Longitudinal Modeling | Part 11 | Quality Assurance | Query resolution | R | REDCap | Randomization | Regulatory Compliance | SAS | SPSS | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan
Education
Roles
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