Jo Chen

With nearly 20 years of experience in clinical research, she has developed extensive expertise in biostatistics, clinical data management, EDC systems, database development, SAS programming, and CDISC standards (SDTM and ADaM). She is a Medidata Rave Certified Builder and possesses comprehensive experience in clinical database design, EDC implementation, and end-to-end clinical trial data management. Throughout her career, she has supported a wide range of Phase I-IV clinical studies across multiple therapeutic areas and has developed a strong understanding of clinical trial workflows, regulatory requirements, and sponsor expectations. In addition, she has contributed to numerous regulatory submission programs, supporting successful marketing applications and approvals by the FDA, EMA, and Health Canada. Her experience spans statistical programming, clinical data standards, submission-ready datasets, and cross-functional collaboration to ensure high-quality and compliant clinical trial deliverables. In her current role, she focuses on understanding client needs, building strategic partnerships, and identifying innovative opportunities to improve clinical trial efficiency and data quality.