statistical programmer岗位职责

Ensure quality control (QC) on all process technical activities related to:
- trial set-up maintenance, and/derived dataset, table, listing, figure programming and/implementation of system applications upgrades/changes to those applications as required in accordance with corporate quality standards, WSOPs / Guidelines, ICH-GCP and/other international regulatory requirements are performed.
-Check own work in an ongoing way to ensure -time quality.
-Maintain all supporting documentation fstudies in accordance with WSOPs/Guidelines to ensure traceability regulatory compliance.
-Proactively participate in quality improvement initiatives.
-Ensure compliance with WSOPs/Guidelines, ICH-GCP any other applicable local international regulations participate in internal/external audits regulatory inspections as required.
-Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial -Management System (CTMS), Safety Reporting, SAS other programming language usage processes within the GRO, biostatistics, medical arenas.
-Provide relevant training mentorship to staff project teams as appropriate.
-Assist project teams in the resolution of problems encountered in the conduct of their daily work.
-Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, required documentation.
-Assist in the production QC of derived dataset specifications, programming specifications, other process supporting documents.
-Use efficient programming techniques to produce and/QC low-medium complexity derived datasets, tables, figures data listings.
Experience:
degree (undergraduate equivalent) in a relevant discipline is preferred equivalent work experience.
Excellent writtenal communication skills.
Relevant Clinical Trial industry experience
Experience working with systems used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting)
其他信息

职责描述：
该职位将执行初级统计编程任务，有机会接受培训并得到进一步发展。
积极进取、团队导向且质量至上的员工有可能晋升至责任更重、级别更高的岗位，并享受极具竞争力的薪酬。及时、准确、高效地完成任务，确保质量和工作效率。工作包括但不限于以下内容：
1. 根据转换要求/规范，在两种不同格式的数据集之间进行数据转换，例如，将Excel数据记录转换至SAS数据集或根据CDISC将数据集规范化。
2. 协助制定SDTM数据映射规范。
3. 根据经批准的数据集规范，对SDTM和ADaM数据集进行编程。
4. 根据统计分析计划 (SAP) 和明确规定的格式，生成准确完整的统计表、清单和图表 (TLG)。
5. 开发并测试SAS程序代码，用于临床试验数据库的逻辑检查和数据报告开发，以便进行数据审查
6. 进行SDTM CRF注释 (aCRF)，或对他人完成的aCRF进行质量审核。
7. 根据SOP和/或临床试验申办方的具体要求，记录数据和编程信息。
8. 根据SOP和/或临床试验申办方的具体要求，对临床试验数据（原始数据、SDTM与ADaM数据集）和编程文件进行归档。
资质及经验要求：
拥有统计学、生物统计学、生物信息学、计算机科学、数学或其他相关领域的硕士学位，并有使用SAS的经验。
SAS认证的初级、高级和临床试验程序员优先。
通过大学英语六级考试 (CET) 者优先。
如果您具备SAS知识，我们将培训您成为专业数据分析师。

要求4年以上sp经验
*好有lead经验
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