プログラミング業務担当

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Job details

Company overview

Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.

Responsibilities

• CDISC標準に準拠したSDTM/ADaMデータセット仕様ならびに関連資料（define.xml, Reviewer’s Guide等）の作成
• 試験中のデータレビュー用プログラム仕様作成、構築
• 統計解析計画書を基にした帳票・グラフおよび解析プログラムの仕様作成
• 承認申請時に必要な電子データの作成ならびに規制当局対応

Requirements

必須条件：

• 医薬品企業もしくはCRO等にて、統計解析業務あるいはCDISC標準に準拠したSDTM/ADaMデータセット作成に関する実務経験が3年以上

Salary

6 - 9 million yen

Location

Tokyo