Helena Chang is a senior biostatistician at the Center for Biostatistics, Icahn School of Medicine at Mount Sinai, with more than 10 years of experience in the design, conduct, and analysis of randomized clinical trials. She participates in the entire lifecycle of a clinical trial and has responsibilities in statistical analyses and data management.  She is involved in all aspects of data management to ensure the integrity, completeness, and consistency of trial data. She develops open and closed session reports for DSMB review, prepares IND/IDE reports for annual submission to the FDA, and assists with clinical summary reports on behalf of study sponsors to the FDA. Helena also provides statistical support including samples size/power calculations, randomization schemes, development of the statistical analysis plan (SAP), analysis of the primary and secondary endpoints as specified in the SAP, manuscript preparation, and dissemination of study results. She has expertise in missing data, longitudinal analysis, and time-to-event analysis. She has interests in incorporating casual inference methods to the clinical trial framework in the presence of missing data and non-compliance, exploring novel methods for composite endpoints, and analysis of patient-centered outcomes.