Senior Biostatistician FSP

Tasks

• Author SOPs related to statistical programming practices
• Calculate sample size
• Collaborate with CROs and vendors to meet timelines
• Develop ADaM specifications
• Develop CRF edit check specifications
• Develop data validation plans
• Develop statistical analysis plans
• Develop study protocols
• Ensure compliance with FDA regulations
• Ensure compliance with Good Clinical Practice
• Interpret statistical results
• Maintain programming tools documentation and validation
• Perform statistical analyses
• Prepare clinical study reports
• Prepare integrated summaries
• Present statistical methodology and results
• Provide data transfer specifications for vendors
• Provide statistical support to clinical studies
• QC efficacy safety tables
• Review CRFs
• Validate analysis datasets

Perks/Benefits

• Career development
• Supportive work environment
• Training

Skills/Tech-stack

ADaM | Analysis datasets | CDISC | CRF | Clinical Practice | Clinical trial | Clinical trial analysis | Efficacy tables | Electronic submissions | FDA Regulations | Good Clinical Practice | Protocol development | QC | R | SAS | SAS programming | Safety tables | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Study Protocol | Study protocol development | TLG specifications