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
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5 - Conduct ad hoc statistical analysis, including surveys utilizing Medical Information Databases (per PMDA requirement)
6 - Be accountable for timely completion and quality of the statistical analysis plan
7 - Collaborate with, direct or monitor programmers and/or statistical teams under supervision.
8 - Perform statistical research or assist in evaluating statistical methodology related to drug development
9 - Implement sound statistical methods related to drug development
10 - Be responsible for result accuracy in study report and regulatory submission documents including archiving documents
Education
PhD or MS in Biostatistics, Statistics, or related fields
Experience
MS with 3 years of experience in drug development; or PhD degree
Competencies
- Advanced knowledge and training in applications of statistical methodologies
- Strong interpersonal and communication skills (native Japanese, verbal and written in English)
- Ability to collaboratively work in matrix environment
- Experience in CDISC, Data Management preferred
- Good working knowledge of SAS and/or R
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