Lead Statistician – Real World Evidence -CDI- M/F

Tasks

• Attend project and study meetings
• Define study objectives and evaluation criteria
• Design real-world evidence studies
• Determine study sample size
• Develop key messages for publications
• Develop statistical analysis plan
• Draft study documents
• Ensure statistical documentation in eTMF
• Interpret statistical results
• Oversee review of statistical documents
• Prepare regulatory submission summaries
• Prepare responses to regulatory questions
• Program statistical analyses in SAS
• Serve as statistical point of contact
• Supervise outsourced CRO activities
• Validate statistical analysis
• Write statistical section of protocol

Perks/Benefits

• Health insurance
• Incentives
• Paid time off
• Profit sharing
• Provident insurance
• Public transport participation
• Remote work

Skills/Tech-stack

Analysis Plan | CDISC | Clinical trials | EMA | ENCePP | Electronic Trial Master File | FDA | ICH | Master File | NICE | Randomized-Controlled Trials | Real-World Evidence | SAS | Statistical Analysis | Statistical Analysis Plan | Trial Master File