Jianhui Zhao
About Jianhui Zhao
Jianhui Zhao serves as the Director of Statistical Programming at Roivant Sciences, where he leads statistical analysis for clinical studies and NDA submissions. With a robust background in statistical programming across various pharmaceutical companies, he has significantly contributed to industry standards and developed tools to enhance project efficiency.
Current Role at Roivant Sciences
Jianhui Zhao serves as the Director of Statistical Programming at Roivant Sciences, a position he has held since 2022. In this role, he leads statistical programming efforts for various clinical studies and regulatory submissions. His responsibilities include overseeing the statistical analysis processes and ensuring compliance with industry standards. Zhao's expertise is instrumental in advancing the company's clinical development programs within the New York City Metropolitan Area.
Previous Experience at AbbVie
Prior to his current role, Jianhui Zhao worked at AbbVie as the Associate Director of Statistical Programming from 2016 to 2022. During his six years in Madison, New Jersey, he led multiple NDA and sNDA submissions, contributing to clinical studies from phase I to III. His experience at AbbVie further solidified his skills in statistical analysis and project management within the pharmaceutical industry.
Background in Statistical Programming
Jianhui Zhao has a diverse background in statistical programming, having worked at several prominent companies in the pharmaceutical sector. He held positions at Forest Laboratories as Principal Statistical Programmer from 2006 to 2014, and at Sanofi as Senior Manager of Statistical Programming from 2015 to 2016. His early career included roles as a Statistical Consultant at Procter & Gamble and Eli Lilly and Company, providing him with a broad foundation in statistical methodologies and practices.
Contributions to Industry Standards
Zhao has made significant contributions to the Clinical Data Interchange Standards Consortium (CDISC) working group, focusing on enhancing industry standards for clinical data. He possesses extensive knowledge of CDISC standards, particularly in SDTM and ADaM data structures. His involvement in these initiatives demonstrates his commitment to improving data quality and regulatory compliance in clinical trials.
Technical Skills and Innovations
Jianhui Zhao has developed multiple utilities aimed at streamlining statistical programming and project management processes. He has hands-on experience in preparing electronic Common Technical Documents (eCTD) for NDA and sNDA submissions. His technical skills contribute to efficient workflows and enhance the overall effectiveness of statistical programming efforts within clinical research.