Statistics Leadership Group

Composed of senior statisticians from IQ member companies, the Statistics Leadership Group (SLG) seeks to address scientific and regulatory challenges in pharmaceutical statistics through information sharing and joint research, and to contribute statistics expertise to the activities of other IQ Leadership Groups.

The SLG is collaborating with other Leadership Groups through the following working groups: Analytical Methods Comparability, Process Analytical Technology, Non-clinical to Clinical Translational Safety, and In vitro Repro/Developmental Assay Predictivity.  The SLG is also providing input to the development of the IQ database framework.

Close monitoring of regulatory development on key statistical issues is another activity of the Leadership Group. Recent topics of interest include statistical requirements for Quality-by-Design regulatory filing, statistical aspects related to large sample sizes, the Process Validation guidance developed by the U.S. Food and Drug Administration in 2011, and the lifecycle approach to validation of analytical procedures with related statistical tools.