Senior Biostatistician FSP

Tasks

• Apply Good Clinical Practice
• Calculate sample size
• Communicate methodology and decision impacts
• Contribute to programming tool standards macros validation
• Create data validation plans
• Define TLG specifications
• Develop CRF edit check specifications
• Develop statistical analysis plans
• Develop study protocols
• Ensure compliance with FDA regulations
• Generate analysis datasets
• Interpret statistical results
• Perform statistical analyses
• Prepare clinical study reports
• Prepare integrated summaries for regulatory submissions
• Provide statistical support to clinical studies
• Review CRFs
• Review or author SOPs work instructions for statistical programming
• Review or author data transfer specifications for vendors

Perks/Benefits

• Career development
• Employee support
• Training opportunities

Skills/Tech-stack

ADaM | Analysis Plan | CDISC | CRF | Clinical Practice | Electronic submissions | FDA Regulations | Good Clinical Practice | QC | R | S&OP | SAS | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Study Protocol | TLG