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【R&D】Programmer, Programming Group, Science & Data Technology, R&D Japan

Location Kita-ku, Ōsaka, Japan Tokyo, Tokyo, Japan Job ID R-073713 Date posted 05/13/2020

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

応募資格(経験、資格等)/ Qualification (Experience & Skill etc)

◆◆経験 / Experience◆◆

<必須 / Mandatory

  • 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

◆◆資格 / License◆◆

<必須 / Mandatory

  • Undergraduate degree or more
  • Certification for SAS Certified Advanced Programmer by SAS Institute

◆◆能力 / Skill-set◆◆

<必須 / Mandatory>

  • Communication and presentation skills in Japanese & English
  • Leadership and logical thinking capabilities

◆◆語学 / Languages◆◆

<必須 / Mandatory

  • business level English or above
  • native level Japanese

◆◆勤務地 / Work Location◆◆

  • Osaka (preferred) or Tokyo

◆◆キャリアレベル / Career Level◆◆

  • D

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.