Yuichiro Kaneko
Schaumburg
Summary
Results-oriented statistician experienced in managing statistical analysis processes for oncology research. Known for strong analytical skills and effective communication with regulatory authorities, ready to leverage expertise to support impactful decision-making and compliance.
Overview
10
10
years of professional experience
Work History
Associate Director, Statistics
Astellas Pharma Global Development Inc.
Northbrook
10.2023 - Current
- Utilized reporting and visualization tools to support governance and team reporting needs.
- Analyzed complex datasets to derive actionable insights and support decision-making processes.
- Analyzed statistical data to generate comprehensive reports that informed strategic decision-making.
- Maintained positive relationships with stakeholders by responding promptly to inquiries, requests and complaints.
- Oversaw statistical analysis processes to ensure compliance with regulatory standards and stakeholder expectations.
Senior Manager, statistics
Astellas Pharma Global Development
Northbrook
10.2021 - 09.2023
- Reviewed completed work to verify consistency, quality, and conformance.
- Oversaw compliance with regulatory standards and company policies during trials.
- Analyzed project data to identify trends and inform decision-making processes.
Manager statistics
Astellas Pharma Inc.
Tokyo
10.2015 - 09.2021
- Reviewed completed work to verify consistency, quality, and conformance.
- Developed and implemented strategies to enhance clinical study design and execution.
- Conducted regular meetings with staff to discuss progress and identify areas of improvement.
Education
Ph.D. - Medical Science
Kyoto University
Kyoto Japan01-2024
Master of Science - Public Health
National Institute of Public Health
Wako Saitama Japan03-2008
Master of Science - Biological Resource Sciences
Tohoku University
Sendai Miyagi, Japan03-2003
Skills
- Statistical programming for R from the range of 'tidyverse', 'ggplot2', 'survival', 'aVirtualTwins', 'SuperLearner', etc
- Statistical programming for SAS from complex data step to the pharmaceutical statistics specific procedure including 'proc seqdesign', 'proc power' to the visualization 'proc sgplot', 'proc sgpanel'
- Oncology statistical analysis theory and implementation from basic to advanced (eg 'KM curve', 'log-rank test', 'Cox proportional hazard model', 'competing risks', 'IPCW' in the context of subsequent therapy, 'cure rate model'
- Several experience for the discussion and response to regulatory authority (FDA, EMA, PMDA, and other agency) at the IND stage, NDA, and subsequent 'RFI: Reguest for Informations' in oncology and autoimmune disease area (Rhuematoid Arthritis)
- Many experience for the statistical discussion and response with PMDA at IND, NDA and subsequent RFI in Japanese, and to facilitate the Non-Japanese colleagues to discuss the questions or comments from PMDA
- Many presentation experience in internal statistical meeting (at least 4 times in one year), and external statistical conference (4 times in JSM, 1 in IBC, 3 times in Japan statistical meeting)
- Several publication experience in clinical studies as lead statistician (more than 10 in Rhumatoid arthritis), and two publications in statistics as first author
- Communication and collaboration with other study team members from different background, regulatory authority, data analysis vendor, external medical and statistical experts
Timeline
Associate Director, Statistics
Astellas Pharma Global Development Inc.
10.2023 - Current
Senior Manager, statistics
Astellas Pharma Global Development
10.2021 - 09.2023
Manager statistics
Astellas Pharma Inc.
10.2015 - 09.2021
Ph.D. - Medical Science
Kyoto University
Master of Science - Public Health
National Institute of Public Health
Master of Science - Biological Resource Sciences
Tohoku University