Led by Sonia Jain, PhD and Nancy Temkin, PhD, the Biostatistics and Analytics Core (BAC) develop study design including sample size justification and power analysis. Drs. Jain and Temkin also write the statistical considerations section of the master study protocol, data and safety analysis plans, and randomization plans and implementation.  The BAC is also responsible for testing of the Electronic Data Capture, writing statistical analysis plans for all primary, secondary, and ancillary analyses, the production of ongoing study progress reports, including DSMB safety and interim/futility analyses reporting, activities to adapt the statistical design during the course of the trial, the final statistical analysis of study data, and interpretation of statistical results.