Senior Biostatistician - Home Based (SA)

Tasks

• Contribute statistical methods and results for CSR
• Create SAP TLF shells
• Create randomization and kit schedules
• Develop SAPs and iSAPs
• Lead biostatistics projects
• Perform sample size calculations
• Prepare DSMB unblinded outputs
• Prepare and present unblinded statistician outputs
• Provide ICH guideline based statistical input
• Resolve client comments with programmers
• Review ADAM and TLFs
• Review sponsor protocol statistical sections
• Support data production for TLGs

Perks/Benefits

• Collaborative work environment
• Home-based work
• Inclusive team culture

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | ADaM | Analysis Plan | CDISC | CFR Part 11 | CSR | Clinical Trial Data | Clinical data | Clinical data programming | Clinical study | Clinical study protocol | Clinical trial | DSMB | Data programming | FDA Regulations | GCP | ICH Guidelines | Part 11 | Project Management | Randomization | SAP | SAS | SAS Macro | SDTM | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Study Protocol | TLF | TLG | Trial data | Unblinded Analysis