Principal Biostatistician - Remote (UK)
Tasks
- Create randomization and kit schedules
- Develop SAPs and iSAPs
- Lead complex clinical trial submissions
- Perform sample size calculations
- Prepare and review CSR statistical methods and results
- Prepare statistical sections of study protocols
- Prepare unblinded statistician outputs for DSMB
- Provide statistical consulting for study design and sample size
- Review and develop ADAM specifications
- Support regulatory guideline compliance
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | Biostatistics | Blinded data | Blinded data handling | CFR Part 11 | Clinical study | Clinical study report | Clinical trial | Clinical trial analysis | DSM B | Data handling | Drug development | FDA | GCP | ISAP | ISO 27001 | ISO 9001 | ISS ISE | MS Office | Part 11 | Project Management | Protocol statistics | Randomization | SAP | Sample Size | Sample Size Calculation | SharePoint | Statistical programming | Trial Analysis | Unblinded Analysis
Education
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