Job Description
ISS Experience (must have)
ADaM (must have)
Spec design
spec review
dataset production
dataset QC
SDTM (should have)
Spec design
spec review
dataset production
dataset QC
TLF Production (must have)
TLF QC (must have)
Define.XML (must have)
Will Be Responsible For
Overseeing CRO who is producing the ISS datasets and outputs
Note: The ISS has 18 studies
Specifically reviewing Integrated ADaM datasets and TLF output
Attending team meetings (possibly lead)
Asking critical questions about the project and process flow (foresee potential difficulties)
Proposing solutions to difficulties in integration
Working closely with the study statisticians throughout the project
Bachelor’s Degree