Birol Emir, PhD, is Senior Director and RWE Statistics Group Lead in the Statistical Research and Data Science Center at Pfizer Inc. In addition, he is a lecturer at Columbia University in New York and External PhD Committee Member at Rutgers University. Recently, his primary focuses have been on big data, predictive modeling and genomics data analysis. He has numerous publications in refereed journals. He recently co-authored a book on Interface Between Regulation and Statistics in Drug Development (Chapman and Hall 2020) and co-edited a book on Statistical Topics in Healthcare Economics and Outcomes Research (CRC Press, 2017). He has taught several short courses and has given invited presentations.