Biostatistician II

Tasks

• Act as statistical contact for project teams
• Determine study outcomes and endpoints
• Develop ADaM specifications
• Develop SDTM specifications
• Develop interim analysis plans
• Develop mock tables listings and figures
• Develop randomization and blinding procedures
• Develop randomization plans and programs
• Develop statistical analysis plans
• Develop statistical methods and results for reports
• Ensure deliverables per CTI SOPs and GCP ICH guidelines
• Maintain records in eTMF
• Perform power analysis and sample size estimation
• Plan clinical study design development
• Program derived datasets
• Validate programming per department SOPs

Perks/Benefits

• Community volunteer opportunities
• Dedicated training department
• Hybrid work opportunities
• Leadership development courses
• Mentoring program
• Work-life balance support

Skills/Tech-stack

ADaM | Analysis Plans | Biostatistics | Blinding | Clinical Practice | Clinical Trial Design | Clinical data | Clinical data management | Clinical trial | Data Management | Derived Datasets | Good Clinical Practice | ICH | Interim analysis | Mock tables listings and figures | Power analysis | Programming derived datasets | Randomization | SDTM | Sample Size | Sample size estimation | Size estimation | Statistical Analysis | Statistical analysis plans | Tables Listings and Figures | Trial design