阎小妍博士，北京大学临床研究所生物统计部主任，长期专注于临床研究的统计设计与数据质量控制，在创新药注册、器械临床评价及真实世界研究等多个领域具有丰富经验。

任职以来，阎博士累计主持和参与注册临床试验及技术服务项目超过300项，涵盖I–III期新药试验、生物等效性研究、真实世界证据支持研究者发起试验（IIT）等。多项成果发表于《Nature Medicine》《JAMA Internal Medicine》《Signal Transduction and Targeted Therapy》等国际权威期刊，具备从方法构建到产品转化的完整链条经验。她参与支持的多个药物和器械品种已成功获批上市，包括多款Ⅰ类化学药和三类创新医疗器械。

在推动行业标准和方法体系方面，阎博士担任多项国家药监局监管科学课题骨干，她主编《生物类似药的研究设计与统计分析》《临床试验数据监查委员会应用实践》等专著，参编《医学统计学》《SAS统计应用》等多部国家级教材，致力于提升统计方法在临床研究中的规范化与实用化。

她社会兼职有中国医师协会循证医学专委会常务委员兼总干事、中国医疗器械行业协会医学数据分析专委会常务委员、中国临床肿瘤学会CSCO生物统计分会委员等，在促进统计方法与行业监管接轨、推动跨学科合作方面发挥了积极作用。

Dr. Xiaoyan Yan currently serves as Director of the Department of Biostatistics at the Peking University Clinical Research Institute. Her primary research interests center on the statistical design and data quality assurance of clinical studies, with extensive applied experience in the domains of innovative drug development, medical device evaluation, and real-world evidence generation.

Since joining the institute, Dr. Yan has led or substantively contributed to over 300 biostatistical consulting and regulatory support projects, encompassing early- to late-phase drug development (Phase I–Ⅳ), bioequivalence assessments, and real-world evidence–based investigator-initiated trials (IITs). Her work has appeared in internationally renowned journals such as Nature Medicine, JAMA Internal Medicine, and Signal Transduction and Targeted Therapy, reflecting her capacity to translate methodological innovation into practice across the full continuum of clinical research. Several of her supported investigational products—notably first-in-class chemical drugs and high-risk Class III medical devices—have obtained regulatory approval in China.

Dr. Yan is also actively involved in regulatory science. She has participated as a core expert in multiple research initiatives commissioned by China’s National Medical Products Administration (NMPA), focusing on methodological development and the formulation of regulatory guidance. She is the lead editor of the monographs Research Design and Statistical Analysis for Biosimilars and Applied Practice of Clinical Trial Data Monitoring Committees, and has co-authored several national-level textbooks, including Medical Statistics and Applied SAS for Statistical Analysis. Her contributions have advanced the standardization and operationalization of statistical methods within the context of regulatory and clinical practice.

In addition to her institutional roles, Dr. Yan holds several academic appointments in national professional societies. She is Executive Secretary and Standing Committee Member of the Evidence-Based Medicine Committee of the Chinese Medical Doctor Association, Standing Committee Member of the Medical Data Analysis Committee of the China Association for Medical Devices Industry, and serves on the Biostatistics Subcommittee of the Chinese Society of Clinical Oncology (CSCO), among others. Her professional activities are distinguished by a commitment to strengthening the integration of statistical science with regulatory decision-making and fostering interdisciplinary collaboration in clinical research.

Panel discussion with:

• Chunpeng Zhao，Associate Director，Statistical Programming，BeOne 赵春鹏，统计编程副总监，百济神州
• John Wang, C3C Chair, Caidya 王军，C3C主席，康缔亚
• Stanley Wei, C3C Vice Chair，Novartis 魏志军，C3C副主席，诺华
• Shijia Wang，Associate Director，Tigermed 王世家，副总监，泰格医药
• Zibao Zhang, General Manager, Union Laiya (Shanghai) 张子豹，总经理，有临来雅