■ 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.