资深程序员 CDISC 专家 FSP
Principal Programmer CDISC SME FSP
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全职嵌入我们的一家制药客户内部，Cytel 会在你身后提供支持，你将处于客户创新的核心。作为首席程序员 CDISC 专家，你将专注于我们一家全球制药客户；这是一家正在推动下一代患者治疗的公司，员工被赋予自主权和责任感。加入这个新项目是一个令人兴奋的时刻。
职位概述：
首席程序员 CDISC 专家在临床研究和监管提交活动中提供专业领域知识和领导力，负责 CDISC 标准的应用、审查和监督。
该职位确保临床数据标准，包括 SDTM、ADaM、CDASH、define.xml、带注释的 CRF、评审指南以及相关的提交交付物，能够一致、准确地实施，并与客户标准、监管期望和行业最佳实践保持一致。
该职位是研究团队、统计学家、程序员、数据管理、科技驱动科学、标准、CRO 及其他跨职能利益相关方的关键 CDISC 顾问。该职位提供基于 CDISC 的数据集和文档的专业审查，支持标准化计划，参与流程文档和培训，并确保临床数据包的提交准备就绪。
最初发布于喜马拉雅山
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Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Principal Programmer CDISC SME you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
The Principal Programmer CDISC SME provides subject matter expertise and leadership in the application, review, and oversight of CDISC standards across clinical studies and regulatory submission activities.
This role ensures that clinical data standards, including SDTM, ADaM, CDASH, define.xml, annotated CRFs, Reviewer’s Guides, and related submission deliverables, are implemented consistently, accurately, and in alignment with client standards, regulatory expectations, and industry best practices.
The role serves as a key CDISC consultant to study teams, statisticians, programmers, Data Management, Technology Enabled Science, Standards, CROs, and other cross-functional stakeholders. The position provides expert review of CDISC-based datasets and documentation, supports standardization initiatives, contributes to process documentation and training, and ensures submission readiness of clinical data packages.
Originally posted on Himalayas