Carolyn Beaudot

Project Biostatistician @Chiesi USA, Inc.

Provides statistical input in support of Drug Development Programs • Provides statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results • Interacts with CROs and supervise statistical activities • Reviews/Develops the Statistical Analysis Plan, including the definition of derived data sets, and the design of statistical tables, figures, and data listings for clinical summary reports • Plans and conducts statistical analysis (ISS, ISE), post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies and/or interact with SAS programmers • Leads all the statistical activities for the Blind Review Meeting • Reviews Clinical Study Reports • Collaborates in writing regulatory document, reviews sections of regulatory submissions, attends meetings with regulatory agencies to support drug registration • Manages the statistical deliverables required by eCTD submission • Reviews abstracts, posters, presentations for publication • Contributes to definition of SOPs