Senior Biostatistician - Remote (UK)
Tasks
- Create SAP TLF shells
- Create randomization and kit schedules
- Develop SAPs and iSAPs
- Lead study submissions and client meetings
- Perform sample size calculations
- Prepare unblinded outputs for DSMB
- Produce CSR statistical sections
- Provide CDISC guided statistical methods input
- Review ADAM and TLFs
- Review protocol statistical sections
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Clinical trials | Drug development | FDA | GCP | ICH | MS Office | Part 11 | Project Management | Randomization | SAS | SAS Base | SAS Macro | SDTM | Sample Size | Sample Size Calculations
Education
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