Senior Biostatistician - Home Based (SA)

Tasks

• Create SAP TLF shells
• Create randomization and kit schedules
• Develop SAPs and iSAPs
• Lead clinical trial biostatistics projects
• Manage project timelines, scope, and resources
• Perform sample size calculations
• Prepare and present unblinded outputs for DSMB
• Prepare and review CSR statistical sections
• Provide CDISC SDTM and ADaM guidance
• Provide ICH guideline based statistical input
• Provide statistical section with minimal support
• Resolve comments with client and programmers
• Review ADAM and TLFs
• Review sponsor protocol statistical section
• Support DSMB as unblinded statistician

Perks/Benefits

• Home-based

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | CSR | Clinical Trial Design | Clinical data | Clinical trial | DSMB | Drug development | FDA Regulations | GCP | ICH E9 | ICH Guidelines | MS Office | Part 11 | Protocol development | Randomization | SAP | SAS | SAS Macro | SDTM | Sample Size | Sample Size Calculation | Scientific writing | Statistical Analysis | TLF | TLG | Trial design | Unblinded Analysis