Statistical Programmer II Guangzhou
当我们的价值观一致时，我们能达到什么样的目标都没有限制。在 Parexel,我们都有相同的目标 - - 改善世界健康。从临床试验到监管，咨询和市场准入，我们提供的每一个临床开发解决方案都是基于某种特殊的东西 - - 我们对所做的事情深厚的信念。无论我们在 Parexal 做什么，我们每个人都有助于开发一种治疗最终会有益于患者。我们把工作作为个人，我们以同情感做，我们致力于改变。关键责任：项目管理 · 协助协调项目启动活动，创建全球计划，跟踪表格和其他必要文件。分配项目的统计编程 ·提供最佳价值和高质量的服务。· 持续检查自己的工作以确保首次的质量。· 使用有效的编程技术来生产衍生数据集 （例如 SDTM,ADaM）,任何复杂性和 QC 低中度复杂性的表格，数字和数据列表。· 帮助制作/QC 衍生数据组规范和其他过程支持的文档和提交文件。· 保持和扩大临床行业内本地和国际监管知识。· 在其他 Parexel 功能领域发展 SAS 以及过程/程序的知识。·酌情为员工和项目团队提供相关培训和指导工作。一般 · 维护符合 SOP/准则的研究支持文件，以确保可追溯性和监管者遵守。· 确保遵守 SOP/指南，ICH-GCP 和其他适用的当地和国际法规，并根据需要参与内部/外部审计和监管检查。· 主动参与进程/质量改善倡议。·了解行业技术标准的监管要求 （例如 CDISC,21 CFR 第11部分和电子提交）.技能：·优秀的分析能力。·掌握 SAS. ·对编程和报告过程的知识和理解。·了解 SOP/指导方针，ICH-GCP 和其他适用的本地和国际法规，如21 CFR 第11部分。·在不断变化的技术环境中学习新系统和功能的能力。·管理竞争优先事项的能力和灵活性来实现国际化。
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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Project Management
· Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
Statistical Programming for Assigned Projects
- Deliver best value and high quality service.
- Check own work in an ongoing way to ensure first-time quality.
- Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.
- Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.
Training
- Maintain and expand local and international regulatory knowledge within the clinical industry.
- Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
- Provide relevant training and mentorship to staff and project teams as appropriate.
General
- Maintain all supporting documentation for studies in accordance
- with SOPs/Guidelines to ensure traceability and regulator compliance.
- Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
- Proactively participate in process/quality improvement initiatives.
- Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
Skills:
- Excellent analytical skills.
- Proficiency in SAS.
- Knowledge and understanding of the programming and reporting process.
- Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
- Ability to learn new systems and function in an evolving technical environment.
- Ability to manage competing priorities and flexibility to change.
- Attention to detail.
- Ability to successfully work as part of a global team.
- Work effectively in a quality-focused environment.
- Effective time management in order to meet daily metrics or team objectives.
- Show commitment to and perform consistently high quality work.
- Business/operational skills that include customer focus, commitment to quality management, and problem solving.
Knowledge and Experience:
- Competent in written and oral English.
- Good communication skills.
Education:
· Educated to degree level in a relevant discipline and/or equivalent work experience.
Originally posted on Himalayas