Statistical Programmer
日本
正社員
- 応募
- 求人を送信
- 求人を保存
Bullet points
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
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Knowledge of SAS and/or other programming languages
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Knowledge of CDISC
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CDISC Knowledge of basic bi, biochemistry and medical/pharmaceutical sciences
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Experience in working in the matrix operating model
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Experience in working in clinical development
条件・待遇
- Work in an international environment, clear career development opportunities, contribute to global clinical studies