Statistical Scientist, Japan

CSL Behring

Koto City, Tokyo

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 Biostatistics interactions with PMDA as part of the response/inspection team.

4 - Provide Biostatistics support (global studies including Japan, Japan standalone studies, PMS) in study data collection, data analysis, reporting, and submission preparation in close collaboration with global DM and Statistical Programming

5 - Conduct ad hoc statistical analysis, including surveys utilizing Medical... More Detail

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