Senior Biostatistician

Tasks

• Collaborate with external and internal partners
• Create and validate programming standards
• Develop CRFs and data validation plans
• Develop study protocols and sample size calculations
• Ensure compliance with FDA regulations
• Perform and interpret statistical analyses
• Prepare clinical study reports
• Present and explain statistical methodology
• Provide statistical support for clinical studies
• Review CRFs and develop analysis plans
• Review and author SOPs and work instructions
• Review data transfer specifications

Perks/Benefits

• N/A

Skills/Tech-stack

ADaM | CDISC | CRF development | Clinical trial | Clinical trial analysis | Data Validation | R | Regulatory Submission | SAS | Sample Size Calculation | Statistics | Study design