Kelvin Shi
About Kelvin Shi
Kelvin Shi serves as the Vice President and Head of Biometrics at Deciphera Pharmaceuticals, where he has successfully led key clinical submissions and study designs since 2018. He has previously held significant roles at Alnylam Pharmaceuticals and AstraZeneca, contributing to the advancement of multiple compounds in clinical development.
Work at Deciphera Pharmaceuticals
Kelvin Shi has served as the Vice President and Head of Biometrics at Deciphera Pharmaceuticals since 2018. In this role, he has been instrumental in the successful delivery of a positive Phase 3 study and submissions in the US, Canada, and Australia under the FDA's Real-Time Oncology Review (RTOR) program and PROJECT ORBIS. His leadership in biometrics has contributed to the advancement of multiple compounds into late-stage clinical studies, showcasing his expertise in clinical trial management and regulatory submissions.
Previous Experience at Alnylam Pharmaceuticals
Before joining Deciphera Pharmaceuticals, Kelvin Shi worked at Alnylam Pharmaceuticals as the Director of Biostatistics from 2016 to 2018. During his tenure, he played a key role in biostatistical analysis and contributed to the strategic direction of clinical studies. His involvement as a core member of the company portfolio strategy committee allowed him to influence innovative study design and portfolio management.
Experience at AstraZeneca
Kelvin Shi's career includes a significant role at AstraZeneca, where he served as Statistical Science Director from 2013 to 2016. In this position, he was responsible for leading statistical analysis and providing insights that supported clinical development decisions. His work contributed to the advancement of various compounds through the clinical trial process.
Education and Expertise
Kelvin Shi possesses a strong background in biostatistics and clinical trial design, which has been pivotal in his roles across various pharmaceutical companies. His expertise encompasses statistical analysis, regulatory submissions, and strategic portfolio management. This knowledge has enabled him to effectively lead teams and contribute to the successful advancement of clinical studies.