高级 SDTM 程序员
Senior SDTM Programmer
** 职位：高级统计程序员** ** 关于 Veramed:** Veramed 是一个生物识别专注的 CRO,主要专门从事统计和统计编程。最近我们也开始扩展到数据管理，并正在英国，美国和印度各地建立专门的数据管理团队。该公司于2012年由统计程序員 Matthew Jones 和统计学家 Emma Jones 创立。过去13年里，Veramed 大幅增长了，现在全球拥有约750-800+名员工。我们在英国有3个办事处，乌克兰有2个办事处，以及位于西班牙，德国，法国和美国的团队。在印度，我们于2024年3月启动了业务，仅两年内已经增长到170名员工，包括承包商。目前我们在孟加拉市设有办公室，海德拉巴德第二个办公室将很快开放。我们的重要优势之一是员工保留率，全球保持率约为9293%. 这一职位提供了与经验丰富的专业人员一起工作，为有意义的临床研究项目做出贡献，并在协作环境中进一步发展你的技术和编程技能**关于角色** 我们正在积极聘请高级程序员。该职位是向各种项目，客户和治疗领域的统计和编程部门提供编程支持。下列的工作任务概述了职位范围。这些任务的应用可能根据当前的业务需求而异。**责任** ** 技术：** - SDTM 数据集开发 - 制定和审查 SDTM 地图规范。- 解释协议，CRF （案例报告表格）和数据管理文件来定义地图。- 使用 R 程序 SDTM 数据集。- 执行独立验证/QC 的 SDTM 数据组和相关输出。-解决不一致性和文档发现。- 进行临床试验文件的一致性检查，包括协议，SAPs,CRF,CSR - 作者并审核简单而复杂的数据集标准 - 执行数据检查和数据探索 （例如使用频率，历史图）- 完成和审查 CDISC 验证工具的报告 - 确保适合标准被应用和遵守 - 熟悉简单的统计技术 （例如，t 测试，ANOVA,回归，标准生存）-项目审查
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**Position: Senior Statistical Programmer**
**About Veramed:**
Veramed is a biometrics-focused CRO, primarily specializing in Statistics and Statistical Programming. Recently, we have also started expanding into Data Management and are in the process of building dedicated data management teams across the UK, US, and India. The company was founded in 2012 by Matthew Jones, a Statistical Programmer, and Emma Jones, a Statistician. Over the past 13 years, Veramed has grown significantly and now has a global workforce of around 750-800+ employees. We have a strong international presence, with three offices in the UK, two offices in Ukraine, and teams located in Spain, Germany, France, and the United States. In India, we launched our operations in March 2024, and within just two years we have grown to 170 employees, including contractors. Currently, we have an office in Bangalore, and our second office in Hyderabad will be launching soon. One of our key strengths is our employee retention, with a strong retention rate of around 92–93% globally. This role offers an excellent opportunity to work alongside experienced professionals, contribute to meaningful clinical research projects, and further develop your technical and programming skills in a collaborative environment
**About the Role**
We are actively hiring for the role of the Senior Programmer this role is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas.
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
**Responsibilities**
**Technical:**
- SDTM Dataset Development
- Develop and review SDTM mapping specifications.
- Interpret protocol, CRF (Case Report Form), and data management documents to define mappings.
- Program SDTM datasets using R.
- Perform independent validation/QC of SDTM datasets and associated outputs.
- Resolve discrepancies and document findings.
- Perform consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs
- Author and review simple and complex dataset standards
- Perform data checks and data exploration (e.g. using frequencies, histograms)
- Complete and review CDISC Validation tool reports
- Ensure the appropriate standards are being applied and adhered to
- Familiarization with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival)
- Review of project management related documents
- Maintain study master file documents and any other documents that are required to be audit ready
**General:**
- Lead internal and client study team meetings effectively
- Present study updates internally and at client meetings
- Share scientific, technical and practical knowledge within the team and with colleagues
- Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
- Build effective collaborative working relationships with internal and client team members
- Seek opportunities to develop innovative ideas, sharing when appropriate
- Line management or mentorship of more junior team members
- Contribution to development of internal training materials
- Contribution to internal process improvement initiatives
**Qualifications**
- Degree in a relevant field such as Mathematics, Life Sciences, Statistics, Computer Science, etc.
- At least 5+ years of relevant industry experience
**Required Skills**
- Strong hands-on experience with **R Programming**.
- 5+ years of hands-on experience in developing **CDISC SDTM** datasets.
- Understanding of clinical drug development process, relevant disease areas, endpoints and study designs
- Good knowledge of CDISC standards and clinical trial processes
- Knowledge of CDISC SDTM Implementation Guide, Define.xml, Pinnacle 21
- Experience reviewing protocols, SAPs, CRFs, and CSR documents
- Awareness of industry and project standards & ICH guidelines
- Demonstrated problem solving ability and attention to detail
- Ability to work independently and as part of a team
- Excellent verbal and written communication skills
- Interpersonal/teamwork skills for effective interactions
- Self-management skills with a focus on results for timely and accurate completion of competing deliverables
**Equal Opportunity Statement**
We are committed to diversity and inclusivity.
**_Veramed is a B Corp_** _accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability._
_As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment._