Clinical evidence sustains or sinks a regulatory submission, and that evidence is built, and defended, with biostatistics. A professional who wants to participate in the development or review of a Statistical Analysis Plan needs fluency with inference, sample size and regression.

This 16-hour Professional Certificate Course introduces inferential statistics (hypotheses, p-values, confidence intervals, Type I/II errors), sample-size and power calculation for continuous and binary endpoints, and linear (OLS) and logistic regression. Exercises are solved in R or an equivalent tool.

The Introductory course prepares participants for the Advanced level (RAQ-650-A), where survival analysis, randomization and blinding, multiplicity and missing data, and the ICH E9(R1) estimand framework are developed in depth.

The Introductory course gives regulatory, clinical-operations and quality professionals the inference, sample-size and regression foundation on which every SAP and clinical-study report depends.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.