Senior Biostatistician - Remote (US)
Tasks
- Create randomization and kit schedules
- Create statistical protocol sections
- Develop statistical analysis plans
- Lead biostatistics projects
- Manage client meetings and CRM activities
- Perform sample size calculations
- Prepare and review CSR statistical sections
- Provide ICH guideline based statistical input
- Provide unblinded statistical outputs for DSMB
- Resolve comments with client and programmers
- Review ADAM and TLFs
- Review protocol statistical section
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Clinical trial | Drug development | FDA | GCP | ICH Guidelines | MS Office | Part 11 | Project Management | Randomization | SAS | SAS Base | SAS Macro | SDTM | Sample Size | Sample Size Calculation | TLF | TLG
Education
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