Biostatistician in the Pharmaceutical Industry

TBD, 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

TBD, 2025

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, Sara serves as a Principal Statistician in Quantitative Sciences & Digital Transformation at Bristol-Myers Squibb. In this role, she supports various biologics development activities, including process development, analytical method development, stability studies, and risk assessments. Additionally, she leads or plays a key role in multiple initiatives focused on automating report generation and routine data analysis. Sara holds a Ph.D. in Biostatistics from the University of Georgia, as well as an M.S. and B.S. in Mathematics from the College of Charleston.

Abstract

Chemistry, Manufacturing, and Controls (CMC) statisticians are crucial in biologics development, providing essential support from pre-clinical through commercial stages of a product’s lifecycle. By applying rigorous statistical methods, they optimize manufacturing processes and analytical methods, leading to consistent and reliable production of biologic therapies. They analyze stability studies to ensure products maintain their efficacy and safety throughout their shelf life. Additionally, they conduct comprehensive risk assessments to identify and mitigate potential issues that could compromise product safety and efficacy, facilitating faster and more efficient regulatory approvals. A career as a CMC statistician is both rewarding and impactful, offering the opportunity to work at the intersection of science, technology, and statistics to make a tangible difference for patients. In this talk, I will share insights into this vital role and how CMC statisticians contribute to the delivery of safe and effective biologic products to improve patient health outcomes.