Zhuo Chen
About Zhuo Chen
Zhuo Chen is the Director of Statistical Programming at BridgeBio, where he has worked since 2021. He has extensive experience in regulatory submissions and holds multiple advanced degrees in engineering, mathematics, and computer science.
Work at BridgeBio
Zhuo Chen serves as the Director of Statistical Programming at BridgeBio since 2021. In this role, he is responsible for overseeing statistical programming efforts and ensuring compliance with regulatory submissions. His work involves direct engagement with regulatory agencies such as the FDA, EMA, HC, and PMDA. Chen operates remotely from Austin, Texas, contributing to the company's mission of advancing innovative therapies.
Education and Expertise
Zhuo Chen holds multiple degrees in relevant fields. He earned a Master of Science in Biomedical Engineering from Tianjin University, where he studied from 1993 to 1996. Additionally, he obtained a Master of Science in Mathematics and Statistics from the University of Minnesota Duluth from 1999 to 2001. He also completed a Master of Science in Computer Science at the University of Minnesota from 2000 to 2002. His educational background supports his advanced skills in statistical programming and analysis.
Background in Biostatistics
Zhuo Chen has extensive experience in biostatistics and statistical programming. Before joining BridgeBio, he worked at Amgen as a Biostatistical Programming Senior Manager from 2015 to 2021. His earlier roles include positions at PPD, where he served as a Senior Programmer Analyst, Programming Manager, and Programming Team Leader. This diverse background has equipped him with a deep understanding of statistical methodologies and regulatory requirements.
Regulatory Submission Experience
Zhuo Chen has hands-on experience with regulatory submissions and responses to various agencies, including the FDA, EMA, HC, and PMDA. He possesses extensive knowledge of CDISC standards, including SDTM, ADaM, CDASH, and define.xml, which are crucial for regulatory compliance. His familiarity with international standards and guidelines such as ICH-GCP and WHO-Drug enhances his capability to navigate the regulatory landscape effectively.
Publications and Recognition
Zhuo Chen has contributed to the field of statistical programming through multiple publications, particularly at PharmaSUG. His work has been recognized with a best paper award, showcasing his ability to communicate complex statistical concepts effectively. This recognition reflects his commitment to advancing knowledge in the field and contributing to best practices in statistical programming.