|勤務地||Japan - Tokyo|
Global Pharma Maker
- 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).
- 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.
-Control outsourcing partners/providers to ensure the quality and appropriateness of deliverables as internal programmers.
-Knowledge of SAS and/or other programming languages
-Knowledge of CDISC
-Knowledge of basic biostatistics, biochemistry and medical/pharmaceutical sciences
-Experience in working in the matrix operating model
-Experience in working in clinical development