Location: Japan - Tokyo
Salary: 8000000 - 12000000 JPY
Job Function: Biostatistics/Data Management
Reference: JO-180323-150093
Industry: Life Sciences & Healthcare
Sub-Industry: Pharmaceuticals


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.