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Statisticians (SAP (Determines how data will be analysed, Organise…
Statisticians
SAP
Determines how data will be analysed
Organise communication of data
Clinical summary reports
Annual updates
Publications
Must be marketed using government approved tables and graphs
Work with regulatory agencies to review the Statistical analysis plan
P-Values
Power goals
Performance goals
Comparison of real world replicability
Regulation of patient safety
Part of the safety team
Monitor adverse events
Must have understanding of regulatory requirements
Relays SAEs to stakeholders
Manages clinical events and monitoring
Review Adverse Events
Select AE's for review by Clinical Events Committee
Data safety monitoring board