Carmen Mak
About Carmen Mak
Carmen Mak is the Vice President of Biometrics, holding a Ph.D. in Biostatistics from the University of Toronto and a Bachelor of Mathematics from the University of Waterloo.
Carmen Mak Vice President Biometrics
Carmen Mak is the Vice President of Biometrics. In her current role, she oversees the biometrics department, ensuring the accurate analyses of clinical data that supports product development and regulatory submissions. Her leadership is rooted in extensive experience in biostatistics and quantitative sciences, ensuring reliable and robust statistical support across various clinical stages.
Carmen Mak Educational Background
Carmen Mak holds a Ph.D. in Biostatistics from the University of Toronto, which provides her with advanced expertise in statistical methodologies and their application in clinical research. She also earned a Bachelor of Mathematics from the University of Waterloo, establishing a strong foundation in mathematical theory and its practical applications.
Carmen Mak Experience at Takeda
At Takeda, Carmen Mak served as the head of the Statistical and Quantitative Sciences for the Vaccines Therapeutic Area. She provided vital statistical leadership in the submission process of a dengue vaccine. Her role involved offering expert guidance on statistical design, analysis, and interpretation, contributing to the vaccine's regulatory submission.
Carmen Mak Role at Mallinckrodt Pharmaceuticals
Carmen Mak was the head of Biometrics at Mallinckrodt Pharmaceuticals, where she oversaw statistical, programming, and data management for their portfolio of products including Acthar® gel and Therakos. She led the submission and approval of Stratagraft®, a treatment for deep partial thermal burns, demonstrating her capacity to manage comprehensive data analysis and submission processes.
Carmen Mak Early Career at Schering-Plough/Merck
Carmen Mak began her career at Schering-Plough, later known as Merck, where she directed statistical support for programs through all stages of clinical development and regulatory submission. This early experience laid the groundwork for her expertise in biostatistics, encompassing everything from early-phase trials to final regulatory approvals.