統計プログラミング及び申請電子データ作成担当者 / Lead Programmer / eData Submission Lead

RWDを活用した承認申請及び自社創製品のグローバル試験の増加に対応していくために，統計プログラミング及び申請電子データ当局提出を担える人財の拡充を行う。

RWDを含む様々なデータを対象に，統計解析計画書に基づいたプログラム仕様，プログラム作成及び品質管理を主導する

CDISC標準に準拠した申請電子データ（SDTM / ADaM）及び申請電子データ関連資料の作成・提出を主導する

Background to recruitment

We conducts statistical analysis programming for clinical trials of products in-licensed from Roche and in-house products, support for preparation of analysis plans for in-house products, and create of analysis results and electronic study data to deliver innovative new drugs to patients in Japan and overseas as soon as possible.

We will expand the number of personnel who can take on the role of statistical analysis programming and eData submission in order to respond to the increase in approval applications using RWD and global studies of in-house products.

Description of work

Lead of creation of programming specifications, program development and quality management based on statistical analysis plans using clinical data including RWD.

Lead of creation and submission of electronic study data (SDTM / ADaM) and electronic study data-related materials conforming to the CDISC standards

Creation list of planned outputs and output layout based on statistical analysis plans.

Negotiation with regulatory authorities on electronic submission data and submission of them to regulatory authorities

Providing of analysis results and responses for inquiries from regulatory authorities

Oversight of statistical analysis programming CROs

Communication with programmers in Roche / Genentech on analytical data and programs

Visualization clinical data to support understanding and insights of data users

Position Features

Through utilizing advanced expertise including data engineering technologies, and collaborating with internal and external stakeholders, we can lead data analysis that enables appropriate decision-making and data submission to regulatory authorities, thereby contributing to the early delivery of innovative patient-centric new medicines to patients in Japan and overseas.

A global development environment has been built with Genentech and Roche, and we can be involved in clinical development of abundant pipelines and clinical development using the latest technology. 応募資格／Qualifications ■求める経験

3年程度）

SAS言語を用いた統計プログラミングの経験，スキル

R言語の経験・スキルを有することが望ましい

CDISCに関する基礎知識

ICHや国内外の規制当局が公表している臨床試験に関する各種ガイドライン等を理解している

TOEICスコア600点以上もしくは同等の英語力

Desired experience

Lead experience in stataistical analysis programming for clinical trials and PMDA's consultation related to the submission of electronic study data at a pharmaceutical company, etc. (3 years or longer)

Experience and skill in statistical analysis programming using SAS language

It is desirable to have R language experience / skills

It is desirable to have knowledge / skills related to visualization tools

Preferred Knowledge and Skills

Basic knowledge on the clinical development process of drugs and medical devices

Basic knowledge of biostatistics

Basic knowledge on CDISC

Understanding of various guidelines, etc. related to clinical trials published by ICH and regulatory authorities in Japan and overseas

Ability to create documents and communicate in Japanese and English

Desired competencies

Leadership skills

Communication skills that enable collaboration in teams

Project management skills

Problem resolution skills

Desired Qualification

Graduated from a science university or higher, or deemed to have equivalent knowledge and skills

TOEIC score 600 or equivalent English skills 待遇／Salary & Benefits ■各種手当

OJT日常業務遂行の中でのスキル向上

OFF-JTと自己啓発

30,000円／月）

Full-Flextime system

To be decided in accordance with our criteria

The notification of working conditions will be made in an electronic file.

If you apply, please understand this point.