Key Accountabilities
• Deliver best value and high quality service.
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
• 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, and required documentation.
• Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
• Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings.
• Check own work in an ongoing way to ensure first-time quality.
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
•Proactively participate in quality improvement initiatives.
• Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
• Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
• Provide relevant training and mentorship to staff and project teams as appropriate.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
• Develop mapping specification for data exports in accordance with applicable standards.
- Familiar with : C ,C#, C++, isual Basic
- Master degree in a science or industry-related work experience
-Commitment to quality management and problem solving.
-Attention to detail and strong organizational skills.
-Advanced proficiency in at least one programming environment.
-Flexible to work in a multi-dimensional environment and on multiple activities.
-Excellent interpersonal skills, good analytical skills and an attention to detail.
-Excellent English skills.
1. 休假制度：第一年15天年假，12天全薪病假，聖誕節放假
2. 薪資制度：年薪13個月
3. 禮金加給：三節與聖誕節禮金、生育津貼、尾牙
4. 多元保險：提供全額付費之員工團保 (包含配偶以及子女) ，依需求可增減保額、 並提供雙親及配偶優惠保險專案
5. 健康檢查：提供年度健康檢查，可依需求增減額度並提供親屬健檢優惠方案
6. 員工訓練：多樣化的線上線下訓練系統與課程、舉辦臨床試驗產業產業新知講座
7. 身心靈課程：瑜珈、烹飪、TRX、親職教育等課程
8. 彈性福利：員工可依個人需求選擇健身房、瑜珈中心、牙科等項目
9. 旅遊補助：提供年度員工旅遊，與員工旅遊特休假期
10. 社團活動：多種社團組織，例如羽球團、桌球團、路跑團、Toastmaster(英語演講社)等
11. 娛樂優惠：員工獎勵點數，可兌換線上商品、合作廠商識別證消費優惠，並提供員工專屬體驗活動
12. 交通便利：彈性工時、位於信義商圈
13. 其他福利：提供免費咖啡以及茶點、慶生會、長期服務獎等
