Shinagawa Manager Japa

Job description

Position Summary The Clinical Data Scientist supports the complete clinical and pharmaceutical drug development lifecycle, including clinical development, regulatory submission, and lifecycle management, through strategic planning, data transformation, statistical analysis, and advanced data science methodologies. This role is responsible for leading or supporting the design, analysis, interpretation, and reporting of clinical trial data, clinical registries, and real-world evidence. Depending on experience level, the individual may act as a Product Owner and represent Biostatistics & Data Sciences (BDS) at project, asset, or substance level within global development teams. Key Responsibilities Lead and/or support statistical analyses, data transformation, interpretation, and reporting for Phase I-IV clinical trials. Contribute to the analysis of clinical registries, observational studies, and real-world data sources. Develop and implement data science solutions to support drug development, regulatory submissions, and evidence generation. Collaborate with cross-functional stakeholders including Clinical Development, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Global Development teams. Ensure statistical deliverables are scientifically sound, regulatory compliant, and delivered according to timelines. Present analytical findings and data-driven insights to internal and external stakeholders. Provide technical leadership and mentorship to team members as appropriate. Contribute to process improvements, innovation initiatives, and implementation of advanced analytical methodologies. Participate in or lead internal and external working groups relevant to clinical data science and statistical innovation. Support interactions with health authorities and regulatory agencies regarding statistical strategy, analyses, and submissions. Required Qualifications Education Bachelor's, Master's, or PhD in Statistics, Mathematics, Data Science, Computer Science, Biostatistics, or a related quantitative discipline. Experience Significant experience in clinical data science, biostatistics, or clinical trial analytics within the pharmaceutical industry, CRO, academia, or regulatory environments. Experience leading statistical activities for clinical development programs. Strong understanding of clinical trial methodology, statistical principles, and drug development processes. Hands-on experience with statistical programming and analytical tools commonly used in pharmaceutical development. Experience working in global, cross-functional development teams. Preferred Qualifications Strong understanding of statistical methodologies used in Oncology clinical development. Experience serving as the study statistician for Oncology clinical trials. Experience supporting PMDA regulatory submissions in Oncology. Ability to communicate effectively in English with global stakeholders, including spoken communication in international meetings. Experience supporting global registration programs. Experience with real-world data and advanced analytics methodologies. Experience serving as project lead and/or scientific mentor. Required Competencies Strong knowledge of clinical trial statistics and experimental design. Ability to interpret complex clinical data and communicate findings effectively. Proactive problem-solving and decision-making skills. Strong stakeholder management and collaboration skills. Excellent presentation and communication capabilities. Fluent English communication skills (written and verbal). Ability to work successfully within global and matrix organizations. Apply now » Find similar jobs: Data Privacy © 2010-2025 Boehringer Ingelheim GmbH. All rights reserved