Job summary
Job category | Technical (Sales / Design / Development / Production Control)/Development / Research / Experimentation / Project Manager |
---|---|
Industry | Health Care/ Other Health Care |
Employment type | Uncategorized |
Position level | Other |
Number of openings | 1 |
Desired entry time | - |
Required language skill |
Japanese (Fluent) English (Business) |
Foreign language competence | - |
Working hours | Others |
Welfares / Leave systems | |
Assistance in visa application | - |
Number of foreign employees | - |
Work details
Company Overview
Global Pharma Maker
Job Description
- 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.
Requirements
-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
About interview
Liaison
SAS Programmer
RGF HR Agent
800 〜 1000 ten thousand JPY