Statistical Programmer

日本 外資系企業 外資系企業
  • Utilize Statistical Programming Expertise to Expedite Clinical Trials
  • Contribute to Approval of Innovative Medicines

企業情報

  • Industry leading European pharmaceutical company, with expertise in oncology, immunology, infectious disease, cardiovascular disease areas

職務内容

  • Produce SASSAS programs and documents (e.g. specifications and mock shell) to deliver the tables, listings, figures (TLFsTLFs), Study Data Tabulation Model (SDTMSDTM) and Analysis Data Model (ADaMADaM) 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.

理想の人材

  • 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

条件・待遇

  • Work in an international environment, clear career development opportunities, contribute to global clinical studies
コンタクト
Ed Marsden
求人番号
4153943
電話
+813 6832 8981

求人情報

職種
勤務地
雇用形態
担当コンサルタント
Ed Marsden
担当コンサルタントの電話番号
+813 6832 8981
求人番号
4153943
企業タイプ