・ Perform duties of a Trial Statistician to support regular clinical trials within national or international development projects or for marketed products as required. Collaborate with members of Clinical Trial Leader and Trial team incl. phamacokineticist in planning clinical protocols conforming to company and regulatory agency guidelines.
・ Support other trial Statisticians in their responsibilities, especially in their statistical responsibilities in the planning and preparation of regulatory submissions and contribute to efforts on cross-trial planning and harmonization.
・ Plan valid, efficient and cost effective clinical trials, typically based on outline provided by Project Statisticians. Prepare Statistical Methodology sections for the protocols and the Trial Statistical Analysis Plans(TSAPs). Support other Trial Statisticians in their responsibilities.
・ Analyze data from phase I to IV trials incl. responsibility for program validation. Support other Trial Statisticians in their responsibilities.
・ M.S in statistics, mathematics, or biometry with three years of experiences in :designing, conducting, analyzing and/or presenting routine trials/studies, and working with a team to apply statistical methodology to a research question.
・ Or a Ph.D. in statistics, mathematics, or biometry (must have received Ph.D. prior to start date with the Company) with graduate level course work, project, consulting or internship experience in writing the statistics section of a protocol or analyze a clinical trial/case study, and working with a team to apply statistical methodology to a research question, and communicating basic statistical information to non-statisticians.
・ Submission experience
・ Good oral and written communication skills (Japanese and English).
・ Attention to Detail Possess a strong quality orientation. Ensure task are completed correctly and on time.