Biostatistics Basics for CMC Scientists and Data Reviewers is a one-and-a-half-day training seminar designed for bench scientists and other non-statisticians who are accountable for the chemistry, manufacturing, and control sections of regulatory submissions. Specifically, it is intended for those who design, develop, and validate analytical methods used to evaluate critical quality attributes of candidate products and for others who generate and/or review assay data used to make decisions during development.

The instructors assume that participants have either no statistical training or limited experience in the application of statistical tools and techniques to CMC science. The course is structured to convey basic critical concepts that are integral to measuring, controlling, and reporting uncertainty of test results and evaluating the inherent risks in making data-driven decisions.

Biostatistics topics covered address questions the instructors have routinely encountered in 20+ years of consulting that reflect inadequate understanding of underlying fundamentals. Generous discussion time is built into the agenda so participants can feel comfortable asking questions or explaining the statistics-based challenges associated with their job responsibilities.

The primary learning objective is to elevate the conversations that non-statistician CMC scientists and reviewers have with their statistician co-workers/consultants.