BIOSTATISTICS

Contribute to the development of protocol

Develop Statistical Analysis Plan (SAP)

Analyze data

Develop Tables and Listings for Clinical Trial Report 

Provide On-going Biostatistical Support 

• Attend team meetings 

• Advice on biostatistics topics

• Attend meetings with partners

• Produce materials for investors o business development presentations

Contribute to all Clinical Study Documentation(integrated,ICH standard) including appendices

Develop Protocols, Synopses, and Appendices

Develop Informed Consent Forms

Prepare Clinical Study Reports (Phase I - IV)

Create Patient Materials to increase compliance and recruitment/retention

Develop SOPs, Work Instructions, Forms and Templates