メディカル・バイオ - 臨床開発モニター

■ 職務内容 / Job Description

Programmer is a key player of conducting data analysis for Japan clinical development as well as for post-marketing surveillance to ensure Japan requirements. Therefore, Programmer surely plays the following roles. Programmer directly reports to the director of Biometrics, Data Science & Innovation.

1. Produce SAS programs and documents (e.g. specifications and mock shell) to deliver the tables, listings, figures (TLFs), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) based on agreement with user representative. Produce accordingly define.xml, Study Data Reviewer's Guide (SDRG), Analysis Data Reviewer's Guide (ADRG) and Analysis Results Metadata (ARM).
2. Lead, contribute and/or support from the aspects of the Programming field toward submissions (including electronic data submission in accordance with CDISC standards), high level documents, responses to inquiries from the healthcare authority, PSUR, re-examination to meet the demands of regulatory authorities, publication activities and commercial works.
3. Control outsourcing partners/providers to ensure the quality and appropriateness of deliverables as internal programmers.
4. Ensure development of all SAS programming and report deliverables are performed in accordance with GCP principles, company policies and SOPs.
5. Provide programming expertise to delivery teams by reviewing documents, e.g. protocols, Statistical Analysis Plan (SAP), Case Report Forms (CRFs) and specifications.

■休日：完全週休二日制, 年末年始

【経験 / Experience】

＜必須 / Mandatory＞

1. Knowledge of SAS and/or other programming languages
2. Knowledge of CDISC

＜歓迎 / Nice to have＞

On top of the mandatory experience,
• Knowledge of basic biostatistics, biochemistry and medical/pharmaceutical sciences
• Experience in working in the matrix operating model
• Experience in working in clinical development

【資格 / License】

＜必須 / Mandatory＞

Certification for SAS Certified Specialist: Base Programming by SAS Institute

＜歓迎 / Nice to have＞

Certification for SAS Certified Professional: Advanced Programming by SAS Institute
Certification for SAS Certified Professional: Clinical Trials Programming by SAS Institute

【能力 / Skill-set】

＜必須 / Mandatory＞

1. Contribution of clinical development from programming perspective
2. Programming skill of SAS and/or other programming language in clinical studies
3. Implementation of new technology & methodology
4. Communication skill

＜歓迎 / Nice to have＞

On top of the mandatory skill-set above,
• Leadership and logical thinking capabilities


【その他 / Others】

＜必須 / Mandatory＞

• Harmonize processes with global

＜歓迎 / Nice to have＞

• Communicate with external experts to search for suitable computer environment in AZ KK
• Learn new methodology and knowledge with respect to machine learning and neural network

■職種未経験者：不可