Provides statistical input in developing the following clinical operational documents:
• Protocols including design, sample size and statistical methods to be used
• Statistical Analysis Plans, including ISE and ISS
• Template Tables, Listings and Figures
Perform statistical operations:
• Randomization code generation
• Statistical Analysis Program Development for reporting of study results for SAP and CSR and other regulatory submissions
• Exploratory or ad-hoc analyses to the requests
Provide statistical support to cross-functional teams:
• Working with Data Manager and Programmer to verify database updates
• Coordinating of data and table review activities
Master or PhD Level in Statistics or Biostatistics with at least 5 year Pharmaceutical company/CRO experience
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