高级统计程序员
Principal Statistical Programmer
职位名称：高级统计程序员
工作地点：北卡罗来纳州达勒姆，美国
工作地点类型：远程
工作合同类型：全职
职位级别：
职位名称：高级统计程序员
职位概述
我们正在寻找一名高级统计程序员，为临床开发项目提供完整的端到端统计编程支持。该职位需要深厚的技术专长、领导力和实际交付能力，涵盖SDTM、ADaM、TLF开发和监管提交支持。高级统计程序员将作为专业领域专家，确保高质量的交付成果，并参与编程标准和最佳实践的制定。
主要职责
- 为临床研究提供从研究设置到提交的端到端统计编程支持
- 领导并执行以下内容的开发和验证：
- SDTM数据集
- ADaM数据集
- 表格、列表和图形（TLF）
- 确保所有交付成果符合CDISC标准和监管要求
- 支持监管提交（例如FDA、EMA），包括define.xml、可提交的数据集和审稿人指南
- 作为高级程序员，根据需要为其他程序员提供技术领导和指导
- 参与并协助维护编程标准、宏和验证流程
- 审查并批准编程交付成果，以确保准确性、一致性和质量
- 与生物统计学、数据管理、临床运营和监管团队紧密合作
- 主动识别风险，并在时间限制内提出高效且合规的解决方案
所需资格
- 统计学、数学、计算机科学、生命科学或相关领域的学士或硕士学位
- 丰富的统计程序员经验，具备明确的高级职责
- 强大的实际操作经验，包括：
- SDTM和ADaM数据集开发
- TLF编程
- 监管提交交付物
- 精通基础SAS和高级SAS，具备良好的SAS宏操作能力
- 深入了解CDISC标准、监管指南和提交要求
- 具备独立从头到尾管理复杂研究的经验
IQVIA是生命科学和医疗行业领先的临床研究服务、商业洞察和医疗智能提供商。我们为一个智能化的连接创造价值。
查看英文原文
Job Title: Principal Statistical Programmer
Job Location: Durham, North Carolina, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job Title: Principal Statistical Programmer
Position Summary
We are seeking a Principal Statistical Programmer to provide full end‑to‑end statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and hands‑on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure high‑quality deliverables, and contribute to programming standards and best practices.
Key Responsibilities
- Provide end‑to‑end statistical programming support for clinical studies from study setup through submission
- Lead and perform development and validation of:
- SDTM datasets
- ADaM datasets
- Tables, Listings, and Figures (TLFs)
- Ensure all deliverables are compliant with CDISC standards and regulatory requirements
- Support regulatory submissions (e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guides
- Serve as a Principal‑level programmer, providing technical leadership and guidance to other programmers as needed
- Contribute to and help maintain programming standards, macros, and validation processes
- Review and approve programming deliverables to ensure accuracy, consistency, and quality
- Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams
- Proactively identify risks and propose efficient, compliant solutions within timelines
Required Qualifications
- Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field
- Extensive experience as a statistical programmer, with demonstrated Principal‑level responsibilities
- Strong hands‑on experience with:
- SDTM and ADaM dataset development
- TLF programming
- Regulatory submission deliverables
- Expert proficiency in base SAS and Advanced SAS with good hands on SAS Macros
- In‑depth knowledge of CDISC standards, regulatory guidelines, and submission requirements
- Proven ability to manage complex studies independently from start to finish
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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Originally posted on Himalayas