Principal Biostatistician (FTE or Contract)
Tasks
- Address clinical team comments on statistical reports
- Conduct statistical analyses and reporting
- Consult on clinical trial statistical activities
- Contribute to trial progression decisions
- Develop analysis datasets and trial reporting outputs
- Develop clinical table listing and graph specifications
- Develop randomization schedule
- Develop statistical analysis plan
- Develop statistical models and validate results
- Ensure compliance with quality standards and guidelines
- Perform interim and blinded data reviews
- Support regulatory reviews and data analyses
- Validate SAS programming deliverables
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | Analysis Plan | Blinded data | Blinded data review | CDISC | CFR Part 11 | COSTART coding dictionaries | Clinical Study Design | Clinical study | Coding dictionaries | Data review | GCP | ICD-9 | ICH GCP | ICH Guidelines | IVRS | Interim analysis | MedDRA | Part 11 | Quality Control | Randomization Schedule | Reporting Tables | SAS | SAS programming | SDTM | Sample Size | Sample Size Determination | Statistical Analysis | Statistical Analysis Plan | Statistical modeling | Study design | Trial reporting | Trial reporting graphs | Trial reporting listings | Trial reporting tables | WHO coding dictionaries
Education
Roles
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