What is CMC Statistics?

Chemistry, Manufacturing, and Controls (CMC) statistical techniques are used:

To assure that the drug sold to the public will have quality attributes similar to those of the drug demonstrated to be safe and effective
To ensure that the quality of the drug meets appropriate standards and is consistent
To assure that the drug you are using is the drug described on the label

Examples of analyses performed by a CMC Statistician

Assist in setting release and stability acceptance criteria for drug product and drug substance
Shelf life determination and expiry extension for drug product
Qualification of reference standards
Calculating control chart limits to monitor manufacturing results
Consult with subject matter experts to design and analyze the results of an experiment
Biosimilarity acceptance criteria to assist in the approval of a biosimilar

What is the difference between a CMC Statistician and a Biostatistician?

Biostatisticians assess the results from patients who experience the drug product during a clinical trial
CMC Statisticians do not address the results from clinical trials