Biostatistics Manager, Statistician

Company

◆グローバルランキング15位以内
◆福利厚生充実且つ、離職率も業界水準よりも低め
◆豊富なパイプラインとコンパウンドを持っており、今後もスペシャリティケア領域を中心に増
◆フレキシビリティの高い働き方を推奨し、定年後も再雇用実績あり

Job Description

Responsible for;
- Ensuring that all statistical aspects of documentation pertaining to clinical programs and non-study 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 the company 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.
Basic Qualifications
- Master degree in Statistics / Biostatistics or other subject with high statistical content, and 3 years 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.

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