募集要項
- 仕事内容
-
You'll conduct data analysis for clinical operations and drug quality control in collaborate with both local and global stakeholders including biostatistics personnel, development team, CRO, etc.
During the new drug development process, you will be involved in the drug application approval and performing statistical analysis based on the regulatory authority.
From time to time, you’ll be in charge of vendor management (CRO) and analysing clinical data for early stage of drug development.
医薬品評価におけるデータ解析を実施する。
国内外の関係者（生物統計担当者、開発チーム）との協力による企画・管理・推進を行う。またに、早期開発の解析標準やCROマネージメントにも担当してもらう。
新薬候補品の治験、承認申請、規制当局対応の統計解析計画を実施する
- 応募資格
-
- 必須
-
Required Experiences:
- 5+ years in pharmaceutical industry
- Strong experiences in statistical analysis applying to clinical development
- Good knowledge of drug application
- CRO Management experiences preferred.
Required Skills:
- Strong background in biostatistics and statistical data analysis.
- Good knowledge of ICH-E3, PMDA’s CTD form, eCRF and GCP
- Good knowledge of SAS software
必須経験
- 5年以上臨床開発経験
- 強い治験の解析における経験
- 承認申請経験
- CROマネージメント経験
必要スキル
- 生物統計学の基礎知識
- ICH-E3, PMDA’s CTD form, eCRF and GCPの知識
- SAS統計解析ソフトウェア経験
- 雇用形態
- 正社員
- 勤務地
- Tokyo / Kanagawa Prefecture
- 年収・給与
- 8 million yen ～ 9.99 million yen
