Title: The role of Statistics in Health Technology Assessments (HTA)

Speaker: Oumar Sy, BMS

Oumar Sy is a biostatistician at BMS. He earned his PhD in Statistics at Kansas State University under the supervision of George A Milliken with an emphasis on design of experiments and mixed models. He currently leads of team of statisticians who provide analyses to gain market access for BMS oncology and hematology assets worldwide. His research interests include analysis methods commonly used in health technology assessments (HTA): indirect treatment comparison, meta analyses and RWE.

Title: Statisticians and Model-informed Drug Development (MIDD): A Brief Look at Pediatric Extrapolation

Speaker: Jim Rogers, Metrum Research Group

Jim Rogers is the Vice President of Statistics in the Quantitative Sciences Business Unit at Metrum Research Group. Jim and his Metrum Research Group colleagues have been influential in advancing the participation of statisticians in model-informed drug development (MIDD), a paradigm that emphasizes using the totality of the evidence to inform decision making. From a methodological perspective, Jim’s focus in recent years has centered on the role of causal inference and transportability concepts in evidence integration.

Abstract: Randomization plays a central role in drug research and development, and rightly so. However, the number of quantitative questions that arise is vastly larger than the number of randomized studies that can be run. The paradigm of model-informed drug development (MIDD) is intended, in part, to address this challenge. Statisticians working in MIDD need to be capable of careful causal thinking and capable of multi-disciplinary collaboration. In this talk we will briefly examine one of the challenges of MIDD, pediatric extrapolation, from a statistical perspective.

Title: Statistics and Dose Optimization in Oncology

Speaker: Frank Shen, BMS

Frank Shen is a biostatistician at BMS. He studied at the University of Delaware for his undergraduate degree, and then received a PhD in statistics from Penn State University. His current work is focused on dose optimization in clinical trials, and applications of Bayesian borrowing for master protocol trials and for external data. In his free time, he enjoys hiking, running, board games, and reading.

Abstract: Dose optimization plays a crucial role in early oncology clinical development.  Recent reviews in oncology show that many approved drugs have large differences between the recommended dose in early development and the final approved dose in the past two decades.  Within that same period, there have been notable drugs that had post-marketing changes in the recommended dose. In response to these challenges, various initiatives, including Project Optimus by the FDA, have emerged to drive innovation in dose optimization. Project Optimus strongly urges sponsors not to use the dose determined in early phase studies as the dose of the Phase 3 study but to conduct dose ranging studies in Phase 2 or 3 to determine the optimal dose. This shift necessitates the development of new statistical approaches to support these changes, presenting an opportunity for statisticians to showcase their value in the field of drug development. Statisticians can contribute by designing new experiments that prioritize dose optimization and by providing the necessary tools to integrate diverse data types, enabling a more comprehensive and integrated approach to optimizing drug dosing.  New Bayesian models can integrate external data, data from different arms of a larger study, or data from an early phase to improve the odds of selecting an ideal dose.  Combined efficacy-safety joint models can empirically balance the need for an effective treatment against safety concerns.   All these new models require more statistical input to assist with implementations and to help clinicians understand their innate assumptions.

Title: The Role of Statistician at Pharma and Statistical Innovations at Servier

Speaker: Denise Yi, Servier

Dr. Huangdi (Denise) Yi is a statistician and expert in health economics and outcome research at Servier Pharmaceuticals in Boston, MA. Holding a Ph.D. in Biostatistics from Yale University, she specializes in advanced statistical methodologies and health economics, particularly in oncology. Dr. Yi's notable achievements include leading critical statistical analyses for HTA submissions and innovating in areas such as indirect treatment comparison and AI/ML methodologies.

Abstract: In the rapidly evolving field of pharmaceutical development, the role of biostatisticians is increasingly pivotal, bridging the gap between complex statistical theories and practical application in drug development. This presentation delves into the transformative impact of statistical innovation in accelerating and optimizing the development of new therapies. Dr. Yi will explore the dynamic role of statisticians who not only design and analyze clinical trials but also contribute significantly to decision-making processes throughout the drug development lifecycle.
Highlighting recent advancements at Servier, the presentation will also cover innovative statistical methodologies. These innovations are crucial in addressing the high costs and uncertainties inherent in developing treatments for conditions with urgent unmet needs, particularly in oncology and rare diseases.

Title: Unveiling the Career Journey: Life as a Biostatistician in the Pharmaceutical Industry

Speaker: Ruiyun Jiang, BMS

Ruiyun is an associate director in Medical Affaires Oncology group in Bristol Myers Squibb. She is Melanoma and Genitourinary therapeutics statistician lead, responsible for the statistical strategies and oversights for the secondary statistical analyses for publications, the statistical review for investigator sponsored studied, as well as the stats lead for medical owned studies. Ruiyun has more than 20 years of experience as a biostatistician in the pharmaceutical industry in multiple therapeutical areas, such as Hematology/Oncology, Infectious disease, Allergy, Multiple Sclerosis, and Erectile Dysfunction. She has led several NDA/EMA filings.

Ruiyun holds a MPH from University of Arizona with the concentration on biostatistics. Currently, she resides in Central New Jersey and has a lovely family with her dearly husband and two beautiful grown-up daughters. She is one of the counselors for Mandarin Young Professional Group fellowship and serves as Sunday School teacher at Rutgers Community Christian Church (RCCC). During her leisure time, she has passions in reading, hiking, swimming and in-house planting and gardening.

Abstract: 1 Why is a career as a biostatistician in the pharmaceutical industry a promising choice? Being a biostatistician in a pharmaceutical company can be a rewarding career. It offers promising prospects due to the industry's growth, the essential role of biostatistics in drug development, competitive salaries, career growth opportunities, interdisciplinary collaboration, and the impact on patient’s health.
2. Day to day work as a biostatistician in the pharmaceutical industry involves various tasks such as: Collaborating with cross-functional teams to design clinical trials, including sample size calculation, randomization methods, and defining statistical endpoints; Developing SAPs that outline the statistical methodologies and procedures to be used for analyzing trial data, including primary and secondary endpoints, subgroup analyses, and handling missing data etc.; Conducting statistical analyses for the clinical trial data; Preparing statistical sections of regulatory documents, such as clinical study reports (CSRs).
3. Biostatistician in Medical affairs: Contributing to the development of manuscripts for publications in scientific journals and presenting study results at professional conferences; Participating in post- marketing studies to evaluate the safety and effectiveness of approved drugs, including observational studies and assessing the long-term outcomes of treatments; Providing statistical guidance and support to cross-functional teams, including clinical development, medical affairs, and regulatory affairs, to ensure appropriate study design and data analysis.
Overall, a career as a biostatistician in the pharmaceutical industry can be intellectually stimulating, challenging, and rewarding. It allows you to contribute to the development of life-saving drugs for the patients while utilizing your statistical skills to make a significant impact on public health.