Erik Bloomquist Founding Co-lead

Erik Bloomquist works at Merck as a Senior Principal Scientist in Hematology. He is the 2025 ASA BIOP Section chair and has research interests in treatment switching and dose optimization.

Email: erik.bloomquist@merck.com

Meijing Wu Founding Co-lead

Meijing Wu was the founding co-lead of this workstream and also co-led the Code Standardization Subteam. In November 2024, the team sadly lost our beloved Meijing due to an accident. Her passing was a profound loss to her family, colleagues, friends, and the statistics community. We honor Meijing's extraordinary contribution and leadership to the workstream, and we are continuing her efforts to advance the research in this important area. Meijing will always be an irreplaceable member of the team. To honor Meijing's legacy, please visit the ASA page.

Bingxia Wang Co-lead

Dr. Bingxia Wang is the Senior Director of Statistics and Quantitative Sciences within the Data & Quantitative Science department at Takeda. She co-leads the working group alongside Ray. With over 15 years of experience in drug development, particularly in oncological disease areas, she is a recognized expert in the statistical design of oncology clinical trials. Bingxia has significantly contributed to shaping regulatory submissions for high-impact oncology products. A frequent speaker at statistical conferences, she shares her expertise to advance quantitative decision-making processes across the field. She also leads and participates in several statistical research working groups, focusing on innovative methodologies for treatment switching and indirect treatment comparisons to support RWE/RWD generation. Bingxia earned her PhD in Biostatistics from Boston University.

Email: Bingxia.Wang@takeda.com

Ray Lin Co-lead

Ray Lin is a Senior Principal Statistical Scientist at Genentech/Roche. He is co-leading this workstream with Bingxia and co-leading the Code Standardization Subteam with Kaifeng and the Method Subteam with Yufei. He joined the company around 15 years ago and had been supporting both early and late stage drug development in oncology. He is passionate about applying statistical methodology to clinical trials and actively participating in multiple cross-company collaborations. He is also enthusiastic in fostering biostatistical communities, including on the Officers team of ASA San Francisco Bay Area local chapter and serving as the Vice President of Career Development and Leadership of the BBSW (Bay-area Biopharma Statistics Workshop). He got his PhD from Stanford University in 2010.

Email: lins24@gene.com

Ananya Roy Tutorial Sub-team Lead

Dr. Ananya Roy is a Senior Director of Biostatistics at Merck, where she works in Oncology late development statistics. Ananya has over 10 years of experience in pharmaceutical industry and has previously worked as a faculty member at University of Nebraska, Lincoln. She holds a PhD in Statistics from University of Florida.

Email: ananya.roy@merck.com

Kaifeng Lu Code Standardization Sub-team Co-lead

Kaifeng has over 23 years of experience in the biopharmaceutical industry, with roles at Lilly, Merck, Forest Laboratories/Allergan/AbbVie, and BeOne. He has a solid background in pharmaceutical development, clinical trials, and observational research across various therapeutic areas, focusing on developing drugs aimed at improving patient survival and quality of life. His work has contributed to the approval of several therapies, including sitagliptin, cariprazine, ubrogepant, and atogepant. Kaifeng has authored over 70 publications in peer-reviewed statistical and medical journals, and his research interests include sample size calculations, missing data handling, multiple comparison procedures, adaptive designs, estimands, and treatment switching. Currently, he serves as Senior Director at BeiGene, where he leads the Statistical Modeling & Simulations group for more than 20 pharmaceutical products in different stages of development. Throughout his career, he has held various roles, progressing from study statistician to therapeutic area head, while fostering collaboration and support within his teams.

Email: kaifenglu@gmail.com

Yufei Wang Method Sub-team Co-lead

Yufei has a background in mathematics and statistics. He is currently leading launch activities at Eli Lilly and provide statistical leadership for market access in oncology. He has over 10 years of experiences in late phase clinical development and market access in oncology, respiratory & metabolic disease, and vaccine. He is interested in causal inference, economic modelling and non-parametric statistics.

Email: yufei.wang2@lilly.com

Abhijoy Saha

Abhijoy Saha is a Sr. Advisor at Eli Lilly and Company, where he applies his expertise in statistical methodology to advance late-phase clinical trials in Oncology and Neuroscience. He earned his Ph.D. from The Ohio State University in 2019 and has since played a key role in designing and optimizing innovative trial strategies. At Lilly, he is responsible for developing statistical approaches for pivotal studies, championing the adoption of adaptive and novel trial designs, and serving as a consultant to cross-functional study teams on statistical trial design.

Email: saha_abhijoy@lilly.com

Charu Gupta

Charu Gupta is currently a Statistical Science Director for Late-Stage Oncology Biometrics at AstraZeneca. With over 15 years of experience in drug development as a biostatistician, she has led statistical strategies for multiple Phase 2 and Phase 3 trials, including developing and implementing new statistical methodologies in clinical research; contributing to complex, innovative study designs; conducting analysis, interpretation, and reporting; engaging in health authority interactions; and supporting NDA submissions. Her technical expertise spans advanced statistical methods particularly relevant to oncology clinical trials, including Cox regression, non-proportional hazards, survival and multivariate analyses, and treatment crossover methodologies. She is proficient in SAS and R programming and holds Base SAS Programmer certification. She holds dual master’s degrees in mathematics and statistics with a specialization in Probability and Statistics, and has been recognized for academic achievements, including certificates in Immuno-Oncology from Harvard University and AI in Pharma from MIT. She is passionate about mentoring and developing the next generation of statisticians, promoting innovation, and enhancing statistical standards across the industry, and she remains committed to advancing the field of biostatistics. She looks forward to contributing her expertise to the broader statistical community

Qingxia Chen

Dr. Chen is a Professor of Biostatistics, Biomedical Informatics, and Ophthalmology & Visual Sciences at Vanderbilt University Medical Center. She also serves as the Vice Chair of Education at the Department of Biostatistics. Her statistical research currently centers around several key areas, including missing data, survival analysis, and Bayesian approaches. Additionally, she is dedicated to the development of statistical methods specifically designed to analyze multimodal data in precision medicine. Notably, she has been actively involved in the All of Us Research Program, contributing her expertise to advance precision medicine initiatives.

Email: qingxia.chen@vumc.org

Heng Wang

Heng Wang is a Principal Data Scientist at Genentech/Roche with a strong focus on innovation and efficiency in clinical trial analysis. She has participated in a variety of cross-industry initiatives, including the R Submission Pilots, which explore the use of R for regulatory submissions. Demonstrating her commitment to open-source collaboration, she was also an early contributor to the development of NEST packages. Her primary interest lies in implementing automation solutions to streamline the clinical trial analysis and reporting process. A key example of her work in this area is the development of autoslideR, a tool designed to automate the creation of presentation slides for clinical reporting.

Email: wangh107@gene.com

Hongwei Wang

Dr. Hongwei Wang is currently a Sr. Research Fellow and Immunology TA Head at Medical Affairs & Health Technology Assessment Statistics of AbbVie. Prior to that, he worked at Sanofi and Merck with increasing responsibilities. Hongwei received his PhD in Statistics from Rutgers University and actively published in real-world evidence, network meta-analysis, advanced analytics and their application to different stages of drug development.

Email: hongwei.wang@abbvie.com

Laura Fernandes

Laura Fernandes is a senior statistical director at COTA Inc., a real world data company specializing in curating oncology EHR data for clinical research. She has a PhD in biostatistics from the University of Michigan in Ann Arbor and has previously worked at the FDA for over 7 years supporting the oncology center of excellence (OCE) as a senior statistical reviewer of oncology and hematology drug applications and at GSK in the biometrics team as a statistical programmer. Her research interest includes real world endpoints in oncology, use of RWD in clinical trials as external controls and oncology clinical trial design.

Email: laurafernandes@cotahealthcare.com

Qing Liu

Qing Liu is a Director of Biostatistics at Amgen, specializing in the advancement of innovative trial designs with statistical strategics and quantified frameworks to support data-driven decision-making across therapeutic areas, with a particular focus on oncology.

Shreya Sreeram

Shreya Sreeram has an M.S. in Health Data Science from UC San Francisco, developing computer vision algorithms to track bleeding in ultrasound images of injured children. With experience spanning clinical lab work, data science internships at Unlearn AI, and cancer research at UCSF, she specializes in applying machine learning and statistical analysis to healthcare challenges. Shreya holds a Bachelor's in Chemical Biology from UC Berkeley and has expertise in Python, R, cloud computing, and predictive modeling, focusing on creating clinically relevant insights that improve patient outcomes. She is currently a product development data science intern working with the DSX and ADS teams at Genentech, and has contributed in setting up and maintaining this website.

Email: shreyasreeram27@gmail.com

Suk-Young Yoo

Suk-Young Yoo is a biostatistician with expertise in statistical analysis and clinical trials. She earned her Ph.D. in Statistics from Purdue University. Currently serving as Director of Biostatistics at Regeneron Pharmaceuticals, she has held progressive roles since 2019, overseeing statistical support for oncology clinical trials, collaborating on clinical development plans, and ensuring regulatory compliance in statistical analyses. Prior to joining Regeneron, she contributed to oncology research at The University of Texas M.D. Anderson Cancer Center.

Email: sukyoung.yoo@regeneron.com

Vickie Zhang

Vickie Zhang serves as the Senior Director of Biostatistics at Servier, where she leads the Hematology and Solid Tumor Oncology Late Phase Statistics group. Before joining Servier, she held key roles at Agios Pharmaceuticals and Novartis, leading a variety of oncology projects. Vickie earned her Ph.D. in Statistics and an M.S. in Neurobiology and Physiology from the University of Connecticut. She has authored numerous peer-reviewed book chapters and manuscripts on methodology, study design, and data analysis. Combining expertise in both statistics and science, Vickie is always passionate about leveraging data-driven decision-making in the pharmaceutical industry.

Email: vickie.zhang@servier.com

Wenjuan (Jessie) Gu

Wenjuan Gu is a Statistical Science Director of Hematology Oncology at AstraZeneca. Before her current position, she worked at the National Institute of Allergies and Infectious Disease as a biostatistician, and then joined FDA as a statistical reviewer and team lead. She supported pre-market reviews and approvals in the Division of Hematologic Malignancies. She was a statistics representative for the Oncology Center of Excellence (OCE) Pediatric Review Committee subcommittee and worked in several Guidance working groups as the statistical representative. She contributed to the guidance and workshops of MRD endpoint for multiple myeloma, evaluation of benefit risk for OS, statistical considerations in subgroup analyses and Bayesian methods in pediatric studies.

Ya Wang

Ya Wang is an Associate Director of Biostatistics at Gilead, with a doctorate degree in Biostatistics from Columbia University. Since joining Gilead in 2018, she has been actively involved in a range of initiatives at the intersection of statistical innovation and software development. Her current work includes the development of R packages, creation of interactive Shiny applications, methodological research, and statistical consultation across various therapeutic areas. She is passionate about open-source software, user-friendly analytics tools, and fostering collaboration in the scientific and healthcare communities.

Yu-Che Chung

Yu-Che Chung works as a senior manager of statistics at Takeda Pharmaceuticals. He primarily works on late-phase oncology studies and has been involved in multiple regulatory submissions. He has many research interests, including Bayesian methods, adaptive seamless designs, treatment switching, and dose optimization.