・Ensuring that all statistical aspects of documentation pertaining to clinical programs and nonstudy activities meet required standards and are statistically correct.
・Influencing study design, and defend statistical approaches internally and externally.
・Influence and contribute to the development strategy undertaken in Japan and defend
internally and externally.
・Adherence to our Policies, SOPs and other controlled documents
Key Activities include
・Partnering and collaborating with GBS and global teams in planning for, and delivering,
outputs needed for Japan.
・Providing strategic inputs and being the key Japan GBS contact for regulatory queries and assist with interactions with Japanese regulatory agencies.
・Contributing GBS localization efforts with us and GBS as needed
【必須（MUST）】・Master degree in Statistics / Biostatistics or other subject with high statistical content, and 3years of directly related statistics experience in pharmaceutical industries.
・Designing, analyzing and reporting of Japanese clinical trials within pharmaceutical /
biotechnology / public health setting in industry, academia.
・Communication of statistical information （written and oral）.
・Experience of working with global team members.
・Communication skills in English for business needs.
【歓迎（WANT）】・Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 1or 2 years of post－graduate statistical experience in the pharmaceutical industry or medical research.
・Knowledge of life cycle drug development （pre－clinical development, clinical development, and post－marketing）.
・Statistical contributions to regulatory submissions in Japan.
・Experience interacting with Japanese regulatory agencies, in particular PMDA.
・Leadership of at least 1 study/project with minimal oversight
・Knowledge of fundamentals of project planning.