ADAM 标准工程师
ADAM Standards Engineer
职位名称：ADAM标准工程师
工作地点：英国伯克郡雷丁
工作地点类型：远程
工作合同类型：全职
职位级别：
职位概述
为部门提供有经验的技术专业知识，以制定流程方法，满足内部和外部客户的需求。计划并协调开发集成编程解决方案，以满足统计编程的全部需求。为部门提供技术专业知识和领导力。提供内部咨询服务，包括复杂项目或客户要求的规格和用户需求分析。
主要职责
• 为复杂研究执行、计划和协调以下工作：(i) 统计程序的编程、测试和文档编写，用于创建统计表格、图形和列表摘要；(ii) 分析数据库（派生数据集）的编程以及数据传输给内部和外部客户。可能执行和计划数据库质量控制检查的编程。
• 编程并计划从多个研究或来源集成数据库。
• 开发并协调编程文档，包括针对复杂研究的计划和规格。
• 在与内部和外部客户合作时提供高级技术专业知识，并独立地为复杂研究向团队和部门提出项目解决方案。
• 执行、计划和协调新流程技术、宏和应用程序的开发、实施和验证。
• 作为统计团队负责人，负责单个复杂研究或一组研究的项目职责。
• 理解工作范围、预算和报价假设，估算已完成的工作量，管理超出范围和资源预测。可能管理项目预算和资源需求，并为单个研究提供收入预测。
• 为低级别员工提供培训和指导。
任职资格
• 计算机科学硕士学历，计算机科学学士学位或相关领域
• 了解统计学、编程和/或临床药物开发流程
• 精通计算应用，如Base SAS、SAS Graph和SAS宏语言
• 良好的组织能力、人际交往、领导能力和沟通技巧
• 能够有效管理多项任务和项目
• 高度准确性和细致的关注
• 能够建立和维护项目计划
查看英文原文
Job Title: ADAM Standards Engineer
Job Location: Reading, Berkshire, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job Overview
Provide experienced technical expertise to develop process methodology for department to meet internal and external clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.
Essential Functions
• Perform, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing summaries and (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients. May perform and plan the programming of database quality control checks.
• Program and plan the integration of databases from multiple studies or sources.
• Develop and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies.
• Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to teams and department, for complex studies.
• Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications.
• Fulfill project responsibilities at the level of statstical team lead for single complex studies or group of studies.
• Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage Out of Scope and resource forecasts for single studies. May manage project budget and resource requirements, and provide revenue forecasts for single studies.
• Provide training and guidance to lower level staff.
Qualifications
• Master's Degree Computer science & Bachelor's Degree Computer science or related field
• Knowledge of statistics, programming and/or clinical drug development process
• Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language
• Good organizational, interpersonal, leadership and communication skills
• Ability to effectively manage multiple tasks and projects
• Excellent accuracy and attention to detail
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
Technical skillset:
- Actively support both the development and ongoing maintenance of standard ADaM metadata programming.
- Strong understanding of CDISC ADaM datasets and experience in managing ADaM standards
- Hands on experience with P21 for data validation
- Basic knowledge and understanding of eSubmission docs (ADRG, DEFINE)
- Knowledge on Tables listings and figures is an added advantage.
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 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.
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Originally posted on Himalayas