Highlights of Statistician Contributions in Pharma

Organizer: Revathi Ananthakrishnan, CG Wang

Speaker: Ruiyun Jiang, Associate Director

Bristol Myers Squibb

Ruiyun is an associate director in the Medical Affaires Oncology group at Bristol Myers Squibb. She is the statistician lead for Melanoma and Genitourinary therapeutics, responsible for the statistical strategies and oversight of secondary statistical analyses for publications, the statistical review for investigator-sponsored studies, and serving as the stats lead for medical-owned studies. With over 20 years of experience, she has worked across multiple therapeutic areas such as Hematology/Oncology, Infectious Disease, Allergy, Multiple Sclerosis, and Erectile Dysfunction, and has led several NDA/EMA filings.

Speaker: Cong Zhu, Ph.D, biostatistician

Regeneron

Dr. Cong Zhu is presently a biostatistician within the Regeneron BDM Medical Affairs Biostatistics team, focusing on oncology therapeutic areas. Prior to this, Cong worked as a biostatistician at Biogen from 2011 to 2023, specializing in the neurological therapeutic area. His role involved supporting digital health studies and evidence generation activities for Global Medical Affairs and Value & Access. Dr. Cong Zhu holds a PhD in Epidemiology, with a minor in Biostatistics, from the University of Texas Health Science Center. His dissertation research, conducted at the University of Texas MD Anderson Cancer Center, concentrated on personalizing radiotherapy to reduce treatment-related immunotoxicity in cancer patients.

Speaker: Greg Cicconetti, Senior Director

Takeda

Greg began his career at Muhlenberg College before joining GlaxoSmithKline, where he worked for 10 years. At GlaxoSmithKline, he focused on osteoarthritis, osteoporosis, pre-term labor, and cardiovascular diseases. Attracted to simulations and graphics, Greg subsequently joined the Statistical Innovations Group at AbbVie, where he helped teams explore the feasibility of adaptive designs through simulation across a broad spectrum of therapeutic areas. Additionally, he organized Advisory Board meetings and Department Conferences. Now at Takeda, Greg leads the Chief Statistical Office, which promotes statistical excellence at all stages of development, providing administrative oversight to the department’s Methodology Hubs. In addition to these responsibilities, Greg continues to consult and supports biomarker development within the company’s celiac program. Greg holds a BA in Mathematics/Statistics from Rutgers College, an MS in Mathematics from Montclair State University, and a Ph.D. in Statistics from the University of Connecticut.

Title: Dose Finding and Phase I/II Clinical Trials Design

Speaker: Soleymani, Samira

Bristol Myers Squibb

Samira received her master’s degree in engineering mathematics from Dalhousie University, Canada, and PhD in Statistics from Western University, Canada. She joined Johnson and Johnson vision care after graduation and worked on utilizing and evaluating machine learning techniques in analyzing potential biomarkers for symptomatic/asymptomatic patients. She played a key role in predicting patient reported outcomes (PRO) for faster evaluation of new materials and designs in Vision Care. She then joined Bristol Myers Squibb, and she held variety of positions in Medical Affair and Early development oncology. She has also published in a variety of medical journals in oncology. Her research has focused on the dose optimization/dose escalation and using Bayesian methodology with historical information in clinical trials.

Biostatistician in the Pharmaceutical Industry

Speaker: Sara Byers, Statistician

Bristol Myers Squibb

Sara Byers is a CMC Statistician with over five years of experience in Design of Experiments (DOE), statistical modeling, data analytics, and process capability. Currently a Principal Statistician in Quantitative Sciences & Digital Transformation at Bristol Myers Squibb, she supports various biologics development activities including process development, analytical method development, stability studies, and risk assessments. She also leads or contributes significantly to initiatives automating report generation and routine data analysis. Sara holds a Ph.D. in Biostatistics from the University of Georgia, along with an M.S. and B.S. in Mathematics from the College of Charleston.

Keynote Session 3: A meaningful career as a pharmaceutical statistician

Speaker: Yili L. Pritchett, VP, Head of Biometrics in Neumora Therapeutics

Neumora Therapeutics

Dr. Pritchett is currently VP, Head of Biometrics in Neumora Therapeutics. Previously, she held the leadership positions as Head of Biometrics for biotech companies or Head of Statistical Therapeutic Areas for large pharmaceutical companies. More proudly to herself, Dr. Pritchett is a dedicated and accomplished statistician who applied statistical sciences to support the advancement of new compounds going through the journey of clinical development, regulatory submission, to becoming the approved treatments that can help patients. Dr. Pritchett started her career by joining Eli Lilly as a Senior Statistician after obtaining her PhD from the Dept of Statistics in University of Wisconsin – Madison. In her 30 years’ service to pharmaceutical industry, Dr. Pritchett has acquired extensive knowledge of drug development in early or late phase clinical trials across broad therapeutic areas of Oncology, CNS, Immunology, Endocrinology, Respiratory, Infectious Disease, Vaccine, and Renal. She was intimately involved and made significant contributions to the successful regulatory submission and approval of 8 drug products. Dr. Pritchett is passionate about using novel statistical methodology to solve challenging problems in the journey of developing a new drug. As a statistical leader for over 18 years, Dr. Pritchett led and coached her teams to deliver with high standards and elevate statistical influence in decision making. Dr. Pritchett has 79 published manuscripts or book chapters. She was elected as a Fellow of American Statistical Association in 2013.