Taku Shimizu is currently a Statistical Programmer at IQVIA Services Japan K.K. He has been a SDTM specialist for 10 years with practical experience of SDTM development (60+ protocols) and implementation with multiple pharmaceutical companies. He has managed all aspects of the SDTM, including define.xml, SDRG, and Attachment 8 for PMDA, development and operation processes (schedules, designs, productions, tests, releases, modifications and maintenances) with efficiency. His skills are SAS, Pinnacle 21, and coordinating Data Manager and Biostatistician peacefully in a view of SDTM Specialist. Taku joined LAB team in 2006. Since 2009, he has been an active member on the SDTM team. He earned a BSc in Biochemistry from the Kyoto Institute of Technology.