Dr. Steven Novick | Nonclinical Biostatistics | Best Researcher Award

Senior Director at Takeda , United States

Dr. Steven J. Novick is a highly accomplished biopharmaceutical statistician with over 25 years of experience in experimental design, statistical analysis, and decision-making within the pharmaceutical industry. As Senior Director of Biostatistics at Takeda, he leads global initiatives in nonclinical and Chemistry, Manufacturing, and Controls (CMC) statistics. His previous leadership roles at Eli Lilly and AstraZeneca reflect his depth of experience in managing diverse teams and driving innovation in preclinical research. A committed mentor and educator, Dr. Novick regularly delivers training on Bayesian statistics and advanced data analysis techniques. He plays a prominent role in the American Statistical Association (ASA), currently serving as Chair-Elect of the Biopharmaceutical Section (ASA-BIOP), and has led numerous conferences and workgroups. With more than 50 peer-reviewed publications and numerous industry accolades, Dr. Novick is recognized for his strategic leadership, scientific integrity, and dedication to enhancing drug development through statistically sound and ethically responsible methodologies.

professional profile

ORCID

Education

Dr. Novick holds a Ph.D. in Statistics (2000) and a Master’s in Statistics (1998), both from North Carolina State University, where he graduated with a perfect 4.0 GPA. His academic foundation was built on a Master of Science in Applied Mathematics from Lehigh University (1995), complemented by dual Bachelor’s degrees in Mathematics and Natural Science from Muhlenberg College (1992), earned summa cum laude. During his academic journey, Dr. Novick received numerous honors including the NSF VIGRE Fellowship, Gertrude M. Cox Fellowship, and several outstanding student paper and achievement awards. His early academic work focused on statistical theory, simulation techniques, and probabilistic modeling, laying the groundwork for a career that would integrate academic excellence with applied pharmaceutical science. These credentials underscore his deep understanding of statistical methodologies and their real-world application in complex biomedical research environments.

Work Experience

Dr. Novick has held senior statistical roles across leading pharmaceutical companies. At Takeda (2023–present), he leads global nonclinical and CMC statistical efforts. Prior, he was Executive Director of Biostatistics at Eli Lilly (2023), overseeing Discovery and CMC statistics. At AstraZeneca (2015–2023), he directed U.S. discovery biostatistics and bioinformatics teams, launching high-impact initiatives across R&D. He served as Senior Statistician at Arlenda (2015), providing Bayesian consulting to major firms. At GlaxoSmithKline (2002–2015), he supported target validation, dose-response modeling, and clinical trial design, earning multiple accolades. Earlier positions include roles at Schering-Plough, Becton Dickinson, and academic appointments at NC State University. Across all roles, Dr. Novick has been a catalyst for methodological innovation, workforce development, and data-driven decision-making. He is also a renowned educator and leader in professional forums, shaping statistical practice through mentoring, publishing, and organizing scientific meetings and training sessions.

Awards and Honors🏆

Dr. Novick is a 2022 Fellow of the American Statistical Association (ASA), recognized for his significant contributions to pharmaceutical statistics. He is a three-time recipient of the Stan Altan Best Nonclinical Biostatistics Paper Award (1st place: 2015, 2019; 2nd place: 2021). He earned the Outstanding Manuscript award from AAPS PharmSciTech in 2010. At AstraZeneca, he received the prestigious 3Rs Award and Early Oncology Award in 2021 for innovating dose-response designs that significantly reduced animal use. Additional recognitions include numerous internal awards at AstraZeneca and GlaxoSmithKline for leadership, innovation, training, and statistical excellence. As a graduate student, Dr. Novick received the NSF VIGRE Fellowship, Gertrude M. Cox Fellowship, and the R.L. Anderson Student Paper Award. These accolades highlight a career grounded in scientific rigor, ethical responsibility, and collaborative impact across academic, corporate, and professional communities.

Research Focus

Dr. Novick’s research bridges statistical theory and pharmaceutical application, focusing on preclinical and CMC biostatistics. His core interests include Bayesian inference, assay development, experimental design, dose-response modeling, and drug combination analysis. He is a pioneer in Bayesian methods for analytical similarity and assay validation and has authored foundational work on robust outlier detection and statistical reproducibility in drug discovery. He contributed to industry guidance on the use of p-values and led initiatives on Quality by Design in preclinical assay development. Dr. Novick also mentors statisticians in Bayesian modeling, machine learning, and regulatory science. Through his leadership in ASA-BIOP, he has championed scientific workstreams that yield real-world regulatory and industry tools. His scholarship and consulting underscore the power of statistical thinking to transform pharmaceutical R&D—from experimental rigor to regulatory compliance and ethical decision-making.

Conclusion

Dr. Steven J. Novick exemplifies the ideal candidate for the Research for Best Researcher Award. His prolific research, sustained leadership, strategic impact in biostatistics, and dedication to mentorship and innovation underscore his outstanding contributions to science and industry. He not only meets but significantly exceeds the typical criteria for this prestigious honor.

Publications to Noted

Jones J., Zhang B., Zhang X., Konings P., Hansson P., Backmark A., Serrano A., Künzel U., Novick S. (2025). Quality by Design for Preclinical In Vitro Assay Development. Pharmaceutical Statistics, 24(1).

Novick S., Zhang T. (2025). Strategy for Designing In Vivo Dose–Response Comparison Studies. Pharmaceutical Statistics, 24(1).

Zhang T., Novick S. (2023). A Comparison of Statistical Methods for Animal Oncology Studies. Pharmaceutical Statistics, 23(1).

Novick S., Zhang T. (2021). Mean Comparisons and Power Calculations to Ensure Reproducibility in Preclinical Drug Discovery. Statistics in Medicine, 40(6), 1345–1358.

Miranda E., Roberts J., Novick S., Lapointe J-M., Bruijnzeel-Koomen C., Thijs J.L., Sleeman M.A., May R.D., Hijnen D.J., Strickland I. (2021). Immunohistochemical Characterization of the IL-13:IL-4 Receptor α Axis in the Skin of Adult Patients with Moderate to Severe Atopic Dermatitis and Healthy Controls. Journal of Investigative Dermatology, 141(2), 382–392.

Novick S.J., Christian E., Farmer E., Tejada M. (2020). A Bayesian Statistical Approach to Continuous Qualification of a Bioassay. PDA Journal of Pharmaceutical Science and Technology, 74(5), 499–512.

Sondag P., Zeng L., Yu B., Yang H., Novick S. (2020). Comparisons of Outlier Tests for Potency Bioassays. Pharmaceutical Statistics, 19(3), 230–242.

Zhao W., Vicini P., Novick S., Anderton J., Davies G., D’Angelo G., O’Day T., Yu B., Harper J., Narwal R. (2019). Detecting Bliss Synergy in In Vivo Combination Studies with a Tumor Kinetic Model. Pharmaceutical Statistics, 18(6), 688–699.

Steven Novick | Nonclinical Biostatistics | Best Researcher Award