Elixir Clinical Research recently announced that Dr. Jie Chen, with 26 years of biopharmaceutical R&D experience, has joined the company as Chief Scientific Officer. Dr. Jie Chen will be responsible for the expansion and management of the company’s Biostatistics and Computational Science Department after he joins Elixir Clinical Research. Science-led and innovation-empowered approaches will be applied to build the Biostatistics and Computational Science Department into a leading team in the CRO industry.

Jie Chen, PhD

Dr. Jie Chen graduated from School of Public Health, Fudan University (formerly Shanghai First Medical College of Public Health) with a medical degree and received his PhD in statistics from Temple University in the United States. He was an American Statistical Association Fellow and a Scholar at Center for Innovative Study design of Stanford University.

Prior to joining Elixir Clinical Research, Dr. Jie Chen worked at Overland Pharmaceuticals as Senior Vice President and Head of Biostatistics and Data Science Department. Previously, Dr. Jie Chen was a Distinguished Scientist in the Biostatistics and Research Decision Sciences Division of Merck Research Laboratories (USA), and he has also held leading positions in global biostatistics and data science at multinational pharmaceutical companies including Novartis, AstraZeneca and Merck Serono.

Dr. Jie Chen has been invited to make keynote/invited presentations at international and regional professional conferences and provided professional training courses, including training courses and presentations at the Regulatory Science and Biostatistics Forum in China, the Regulatory-Pharmaceutical Industry Statistics Workshop (RISW) of American Statistical Association, the Statistics Workshop of European Medicines Agency (EMA), and invited presentations at numerous universities worldwide. He is currently on the editorial boards of Contemporary Clinical Trials and the Journal of Biopharmaceutical Statistics, and is a co-chair of the Scientific Working Group on Real-World Evidence (RWE) of American Statistical Association (ASA) and a co-convenor of the Scientific Working Group on the Application of RWE in Master Protocol Trials. Dr. Jie Chen has authored the book Medical Product Safety Evaluation: Biological Models and Statistical Methods and published more than 40 academic papers. His two monographs Real-World Data and Evidence: An Interdisciplinary Approach to Precision Medicine and Precision Health Care and The Intersection of Clinical Trials and Real-World Research will be published soon.

Dr. Jie Chen is well versed in the application of biostatistics in all phases of drug development, especially in the design of phase 1-3 clinical trials (e.g., dose-escalation design, PoC study design, adaptive design, enrichment design, subgroup analysis, superiority/non-inferiority study design, multi-regional clinical trial design, single-arm trial design, master protocol design, etc.), data analysis, interpretation of results and real-world data and evidence to support drug development and regulatory decisions, etc. He has also been a key member of independent data and safety monitoring committees for several large clinical trials and has participated in or supported nearly 20 successful new drug applications (NDA/BLA) in a variety of therapeutic areas including oncology, cardiovascular, diabetes, respiratory, infection, vaccines, metabolism, dermatology, and psychoneurological disorders.

Mr. Liedong Xu, General Manager of Elixir Clinical Research said:

“We are very pleased to have Dr. Jie Chen join us. He has excellent industry vision and rich practical experience in biopharmaceutical R&D, especially in the field of biostatistics and data science, and has achieved many outstanding achievements. Under Dr. Jie Chen’s leadership, we look forward to further enhancing our global customer service capabilities, improving R&D efficiency, accelerating the innovation process, and helping more innovative drugs reach patients worldwide.”

Dr. Jie Chen said:

“I am very honored to join Elixir Clinical Research, which is committed to providing pharmaceutical companies with high-quality, efficient, innovative and compliant digital clinical research solutions, with information technology software applications covering the whole process of clinical trials and strong data analysis capabilities, and has unique advantages in the field of biopharmaceutical R&D. I look forward to working with the team in the future to help our clients accelerate their clinical development and commercialization process and make more good drugs accessible.”