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The Biostatistician in Japan provides statistical contribution to a clinical development program, including e-data and CDISC for submission to PMDA. The Biostatistician implements statistical strategies for clinical trials and regulatory submissions, and is accountable for statistical deliverables. The position is to collaborate with all therapeutic areas. More specifically: 1 - Support development of components (CSR, CTD, CDISC, e-Data, DSUR) for submission to PMDA and interact with global and local team 2 - Perform quality control of the key e-data and CDISC deliverables 3 - Support... more ->