Principal Biostatistician - Home Based (SA)

Tasks

• Collaborate with sponsors and regulatory teams
• Create randomization and kit schedules
• Develop statistical analysis plans and shell programs
• Ensure compliance with regulatory guidelines
• Lead complex clinical trial projects
• Manage project timelines, scope, and resources
• Perform sample size calculations
• Prepare and review statistical methods and results for CSR
• Review and develop ADAM specifications
• Review and draft statistical sections of clinical protocols
• Support DSMB unblinded outputs
• Use CRO systems for document checks and SharePoint access

Perks/Benefits

• Global career growth
• Great place to work
• Home-based work
• Inclusive workplace
• Innovative work environment
• Supportive team

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | ADaM | ADaM specifications | Analysis Plan | Biostatistics | CFR Part 11 | Clinical data | Clinical study | Clinical study report | Clinical trials | DSM B | Data Safety | Data Safety Monitoring Board | Data safety monitoring | Drug development | FDA | GCP | ISAP | ISO 27001 | ISO 9001 | Kit Schedules | MS Office | Part 11 | Protocol development | Randomization | Randomization Schedules | Regulatory Compliance | SAP | Sample Size | Sample Size Calculation | SharePoint | Statistical Analysis | Statistical Analysis Plan | Statistics | Submission ISE | Submission ISS | Unblinded Statistics