Bakhshi

WORK HISTORY

EDUCATION

ABOUT BAKHSHI

Conducted research and developed statistical methodologies for Phase I Clinical Trials and Bioavailability/Bioequivalence (BA/BE) trials- Proficient in various trial designs, including parallel, crossover, group allocation, factorial, equivalency, non-inferiority, and adaptive designs- Over seven years of expertise in statistical programming using R, SAS/BASE, SAS/STAT, SAS/MACRO, and SAS/Graph- Developed Statistical Analysis Plans (SAPs) and corresponding tables, figures, and listing (TFL) shells for studies ranging from simple to moderate complexity- Performed and conducted quality control (QC) reviews for statistical analyses of studies with varying complexity- Strong foundation in descriptive and inferential statistics, as well as statistical methodologies- Addressed deficiency letters from regulatory agencies effectively- Created randomization schedules utilizing SAS programming- Applied statistical methods such as regression analysis, time series analysis, logistic models, generalized linear models (GLM), ANOVA, hypothesis testing, and forecasting techniques- Researched and developed curve alignment methods within the field of Functional Data Analysis (FDA)- Experienced in Functional Data Analysis and machine learning algorithms.