This position is responsible for supporting the phase 3 clinical trial, including but not limited to, as outlined below:
- Reviews SAP, TLG shells and variable derivation rules and provides feedback.
- Develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues to ensure high quality study data.
- Develops the Data Monitoring Committee charter in collaboration with other functions and liaises with independent statisticians.
- Reviews the SAP, provides feedback to the statistician and develops (with the statistician) study specific dataset specs.
- Performs and validates statistical analysis.
- Independently reviews CSRs and performs data interpretation.
- Supports submission strategy planning, regulatory communication and development of Health Authorities responses.