Statisticial Analyst

Tokyo 23 Wards Permanent Foreign Multinational
  • Utilize Statistical Programming Expertise to Expedite Clinical Trials
  • Contribute to Approval of Innovative Medicines

About Our Client

  • Well known global Contract Research Organization with growing presence in APAC

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 Meta data (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.
  • Ensure development of all SAS programming and report deliverables are performed in accordance with GCP principles, company policies and sponsor SOPs.
  • Provide programming expertise to delivery teams by reviewing documents, e.g. protocols, Statistical Analysis Plan (SAP), Case Report Forms (CRFs) and specifications.

The Successful Applicant

  • Knowledge of SAS and/or other programming languages

  • Knowledge of CDISC

  • CDISC Knowledge of basic bi, biochemistry and medical/pharmaceutical sciences

  • Experience in working in the matrix operating model

  • Experience in working in clinical development

What's on Offer

  • Work in an international environment, clear career development opportunities, contribute to global clinical studies
Contact
Ed Marsden
Quote job ref
4195647
Phone number
+813 6832 8981

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
4195647
Company Type