Biostatistician - Romania

Tasks

• Calculate or validate sample sizes
• Conduct interim analysis support
• Develop TLF shells
• Develop risk-based monitoring plans
• Develop statistical analysis plans
• Develop unblinding plans
• Ensure CDISC and ICH compliance
• Manage biostatistics deliverable timelines
• Monitor trial budget forecasts
• Perform clinical trial data analyses
• Review CSR statistical sections
• Review SDTM domains and ADaM datasets
• Review budgets and change orders
• Review protocol statistical sections
• Review randomization plans and lists
• Support data management data cleaning

Perks/Benefits

• Flexible schedule
• Home-based position
• Ongoing learning and development
• Permanent full-time position
• Remote work in Romania

Skills/Tech-stack

ADaM | Analysis Plan | CDISC | Clinical trials | Controlled Terminology | ICH E6 | ICH E9 | ICH E9(R1) | ICH E9R2 | Randomization | Risk-Based Monitoring | Risk-based | SAS | SDTM | Statistical Analysis | Statistical Analysis Plan | Unblinding