Senior Biostatistician FSP

Tasks

• Author or review data transfer specifications
• Build ADaM specifications and QC datasets
• Calculate sample size
• Create integrated summaries for regulatory submissions
• Create standards for programming tools and outputs
• Define TLG specifications
• Develop CRFs, edit checks, and data validation plans
• Develop statistical analysis plans
• Develop study protocols
• Ensure FDA compliance and GCP
• Generate analysis datasets
• Perform statistical analyses and interpret results
• Prepare clinical study reports
• Review CRFs and data review guidelines
• Review or author SOPs and work instructions
• Support statistical analyses for clinical studies

Perks/Benefits

• Supportive team culture
• Training and development

Skills/Tech-stack

ADaM | Analysis Plan | Analysis dataset | CDISC | CRF review | Clinical Practice | Data QC | Electronic submissions | FDA Regulations | Good Clinical Practice | Protocol development | R Programming | SAS | SAS programming | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Study Protocol | Study protocol development | TLG specification