Statistical support of individual studies and clinical summaries for new drug application

Support multiple phase I studies (compounds and indications - design, analysis, and writing of statistic section of CSR); Design and analysis of 2 thorough QT studies; Analysis of several phase III studies - including writing of statistical sections of CSR; Support submission of 3 compounds for health authority approval, interact with health authority in regular basis; Conducted and concluded one large registration Phase III trial; Worked as company contact person for 2 DMCs; Published more than 10 articles;

Supported 2 registration trial in CNS.

Protocol statistician for several studies (Phases I and III); Prepared SAP and help lock databases; Guided statistical analyses and supported CSR writing.

Protocol statistician; Supported database lock; Analyzed clinical studies and supported CSR writing;