Senior/Principal Statistical Programmer(高级/首席统计程序员)

工作地点:上海张江


In this role you will provide statistical programming support for drug products including analysis and reporting clinical studies, and regulatory submissions.

 

该岗位要求您为药物临床开发提供统计编程支持,包括数据分析、临床研究报告撰写及按法规要求提交申报等。

 

岗位职责/Job Responsibilities

1.    produce the SDTM and ADaM datasets and tables, listings, and figures per programming specifications, Statistical Analysis Plans, and other study relat Act as the lead programmer for the studies

2.    Independently ed documentation

3.    Create and validate case report data deliverables (SDTM dataset, Define.XML, SDRG, aCRF)

4.    Create and validate analysis dataset deliverables (ADaM datasets, Define.XML, ADRG)

5.    Able to generate regulatory submission-ready packages in an eCTD format including usage of Pinnacle 21

6.    Ensure SAS programs adhere to SOPs and guidance

7.    Develop SAS programs, standards macros to enhance the process

8.    Deliver products with high quality per agreed timelines

9.    Participate in the structure and content review of SDTM, SEND, ADaM datasets and maintain validation documentation

10. Provide feedback on CRFs, Statistical Analysis Plans, and templates

11. Provide input for the creation of database and analysis specifications

12. Provide statistical programming for ad-hoc requests.

 

1. 担任研究项目的首席程序员

2. 根据编程规范、统计分析计划和其他相关研究文件,独立生成SDTMADaM数据集及表、清单和图表

3. 创建和验证案例报告数据文件(SDTM数据集,Define.XMLSDRGaCRF)

4. 创建和验证分析数据集文件(ADaM数据集,Define.XMLADRG)

5. 能够按照监管机构要求生成eCTD格式文件,如使用Pinnacle 21

6. 确保SAS程序遵从公司SOP和相关指导原则要求

7. 开发SAS程序及标准宏程序以提高工作效率

8. 按照约定的时间期限交付高质量的产品

9. 参与SDTMSENDADaM数据集结构和内容审核并维护验证文档

10. 提供对 CRFs、统计分析计划和模板的反馈

11. 为建立数据库和分析规范提供建议和指导

12. 为特定项目要求进行统计编程

 

任职资格/Qualifications

1.    Bachelor’s Degree in Statistics, Computer Science, Mathematics, or related discipline

2.    Four years’ SAS programming experience in international pharmaceutical/biotech/CRO industry

3.    Experience in clinical drug development, regulatory requirements

4.    Proficient in SAS programming including SAS Base, SAS/STAT, SAS Macro, ODS, SAS/Graph

5.    Expert knowledge of CDISC SDTM and ADAM requirements for submission

6.    Proven ability to produce report quality tables graphs and data listings without direct supervision

7.    Demonstrated ability to support multiple difficult assignments with challenging timelines

8.    Solid problem-solving skills, attention to detail, good verbal and written English communication skills

 

1. 统计学、计算机科学、数学或相关专业学士学位

2. 4年跨国药企/生物技术/CRO 行业 SAS编程经验

3. 丰富的临床药物开发经验,熟悉相关法规要求

4. 熟练应用SAS编程模块,包括SAS BaseSAS/STATSAS宏,ODSSAS/Graph

5. 专业的CDISCSDTMADaM)知识以满足监管机构的文件提交要求

6. 能够在极少监督的情况下生成高质量的报表、图表和数据清单

7. 能够在有限时间内处理多项困难任务

8. 扎实的解决问题能力,注重细节、良好的英语口头和书面沟通能力

 

请将您的简历发送至:HR@xihuasci.com(请注明应聘职位)

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