お仕事情報

お仕事情報

統計解析マネージャー:SS-3670MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

世界最大の独立バイオテクノロジー企業と、内資系研究開発型グローバル製薬企業との合弁会社

求人コード SS-3670MY
募集職種 統計解析マネージャー
職務内容 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 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.
応募要件 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.

Preferred Qualifications
- Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 1 or 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 postmarketing).
- 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.
- Communication skills in English for business needs.
勤務地 東京
年収 1000万円~1300万円
最終学歴 理系大卒
推奨される資格要件 理系
その他

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