Biostatistician in the Pharmaceutical Industry

Thursday, Aug 14th, 2025

Speaker: Ruiyun Jiang, Associate Director

Bristol Myers Squibb

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 a counselor for Mandarin Young Professional Group fellowship at Rutgers Community Christian Church (RCCC). During her leisure time, she has passions in reading, hiking, swimming and in-house planting and gardening.

Abstract

The Role of a Biostatistician in the Pharmaceutical Industry and Medical Affairs

Being a biostatistician in a pharmaceutical company is a rewarding career. It offers promising prospects due to the industry's growth, the essential role of biostatistics in drug development, interdisciplinary collaboration, the impact on patients' health, career growth opportunities, and competitive salaries.

As a biostatistician in the pharmaceutical industry, you will be involved in various tasks such as collaborating with cross-functional teams to design clinical trials, including sample size calculation, randomization methods, and defining statistical endpoints. You will also develop Statistical Analysis Plans (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. Additionally, you will conduct statistical analyses for clinical trial data and prepare statistical sections of regulatory documents, such as clinical study reports (CSRs).

There are some unique features of being a biostatistician in medical affairs. The focus of work in medical affairs shifts from drug development to addressing the needs of healthcare professionals (HCPs) and patients. The scope of work includes developing manuscripts for publication in scientific journals, 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. Furthermore, you will generate evidence that differentiates and unlocks the full potential of approved medicines across their lifecycle for patients.

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 patients while utilizing your statistical skills to make a significant impact on public health and patients' lives.

Statistical Excellence: How CMC Statisticians Drive Biologic Product Success

Thursday, Aug 14th, 2025

Speaker: Cong Zhu, 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.

Abstract

TBD

Statistical Excellence: How CMC Statisticians Drive Biologic Product Success

Thursday, Aug 14th, 2025

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.

Abstract

TBD

Dose Finding and Phase I/II Clinical Trials Design

Thursday, Aug 14th, 2025

Speaker: Soleymani, Samira, Biostatistician

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.

Abstract

TBD