高级临床分析师与程序员-印度
Senior Clinical Analyst and Programmer-India
职位描述
高级临床分析师和程序员将负责各种用途的编程工作，包括用于数据审查、安全审查清单、集中监控清单和报告的不同数据清单。高级临床分析师和程序员需要收集、理解和分析数据管理（DM）和基于风险的研究管理（RBSM）部门报告的需求，并在约定的时间和预算内创建代码来满足这些需求。该职位将协助开发和维护最佳策略，以提高生产率和质量，同时减少周期时间和成本。此外，高级临床分析师和程序员必须确保所有这些活动符合适用的监管要求、行业指南和Indero的标准操作规程（SOP），同时尊重Indero对客户要求和时间表的承诺。
更具体地说，高级临床分析师和程序员必须：
- 根据主要来自DM和RBSM的用户需求创建清单规范。
- 基于方案、EDC数据库和数据验证规范创建SAS数据审查清单。
- 创建手动数据审查清单库。
- 创建安全审查清单。
- 积极参与创建支持集中监控的报告和清单。
- 记录代码和规范的更改。
- 协助制定与数据标准实施相关的标准操作规程（SOP）。
- 协助开发和维护提高生产率和质量、同时减少周期时间和成本的策略。
- 作为导师指导更初级的分析师和程序员。
任职要求
教育背景
- 需要获得理学学士学位；
- 计算机科学、信息系统、统计学、工程或相关领域的硕士学位为加分项；
工作经验
· 至少10年的生物技术、制药或CRO行业的临床研究经验，包括5年SAS编程经验；
知识和技能
- 精通监管要求和药物开发流程；
- 有临床试验数据、SAS数据和数据库规范的长期接触经验；
- 拥有SAS认证和/或高级程序员经验为加分项；
- 非常有条理且注重细节，具备有效的项目规划和时间管理能力。
查看英文原文
Description
The Senior Clinical Analyst and Programmer will lead the programming activities for various purposes including different data listings to be used for data review, Safety Review Listings, Centralized Monitoring Listings and Reports. The Senior Clinical Analyst and Programmer will be responsible to gather, understand and analyze the needs reported by the Data Management (DM) and Risk Based Study Management (RBSM) departments, and to create code to answer these needs within agreed timelines and budget. This person will assist with development and maintenance of optimal strategies to increase productivity and quality, while decreasing cycle times and costs. In addition, the Senior Clinical Analyst and Programmer is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.
More specifically, the Senior Clinical Analyst and Programmer must:
- Create listing specifications based on user requirements mainly from DM and RBSM.
- Create SAS Data Review Listings, based on protocol, EDC Database and Data Validation Specs.
- Create a library of Manual Data Review Listings.
- Create Safety Review Listings.
- Actively participates in creating reports and listings to support Centralized Monitoring.
- Document changes to code and specifications.
- Assist in the development of Standard Operating Procedures (SOPs) related to the implementation of data standards.
- Assist with development and maintenance of strategies to increase productivity and quality, while decreasing cycle times and costs.
- Serve as a mentor to more junior Analysts and Programmers.
Requirements
Education
- A Bachelor of Science degree is required;
- Master's degree in Computer Science, Information Technology Systems, Statistics, Engineering, or a related field, an asset;
Experience
· At least 10 years of clinical research experience in the biotechnology, pharmacy or CRO industry, including 5 years of SAS programming;
Knowledge and skills
- Excellent knowledge of regulatory requirements and the drug development process;
- Extended exposure to clinical trial data, SAS data, and database specifications;
- SAS certification and / or Advance Programmer experience would be assets;
- Very organized and focused on details, with effective project planning and time management skills;
- Strong verbal and written communication skills in English;
- Ability to work in a high-speed environment with proven agility to juggle and prioritize multiple competing demands;
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
Work location
Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.
About Indero
A Global Clinical Leader In Dermatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in India.
Originally posted on Himalayas