転職・求人情報の詳細をご覧になる場合は会員登録（無料） が必要です
| 部署・役職名 | Biostatistics Mgr_Statistician |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Responsible for ・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 |
| 労働条件 | 屋内原則禁煙 |
| 応募資格 |
【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. |
| 更新日 | 2020/12/10 |
| 求人番号 | 1590211 |
採用企業情報
- 企業名は会員のみ表示されます
- 会社規模101-500人
この求人の取り扱い担当者
-
- ?
- ヘッドハンターの氏名は会員のみ表示されます
会社名は会員のみ表示されます
-
- メディカル
-
