Statistical Programmer
上海德琪医药科技有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2022-06-30
- 工作地点:上海-长宁区
- 工作经验:2年经验
- 学历要求:本科
- 职位月薪:2-4万
- 职位类别:生物工程/生物制药
职位描述
Responsibilities:
1. Study Programmer:
-Develop programs to produce SDTM/ADaM datasets, tables, listings, and graphs according to specifications
-Develop specifications
-Performs ad-hoc analysis as requested
2. Perform quality control, as required per SOPs, for statistical programming deliverables
3. Provide items required for submission (i.e. SAS transport files, define.pdf/xml, annotated CRF)
4. Implement and contribute to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection/review
5. Oversee the programming tasks of CRO vendors
Qualifications & Certificates:
1. B.S. or M.S. degree in quantitative science disciplines, Statistics, pharmacy or related disciplines
2. Base SAS, SAS/STAT, SAS Graph and SAS Macro, Strong SAS programming skills, and other statistical and data processing software e.g. R/ Python.
3. Good oral and written communication skills in Chinese and English
4. At least 2-year experience in clinical data analysis
5. Ability to independently manage multiple tasks and projects
6. Familiar with CDISC standards(SDTM IG, ADaM IG, Define requirement)
7. Knowledge of clinical drug development process, and applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesStatistical Programming
1. Study Programmer:
-Develop programs to produce SDTM/ADaM datasets, tables, listings, and graphs according to specifications
-Develop specifications
-Performs ad-hoc analysis as requested
2. Perform quality control, as required per SOPs, for statistical programming deliverables
3. Provide items required for submission (i.e. SAS transport files, define.pdf/xml, annotated CRF)
4. Implement and contribute to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection/review
5. Oversee the programming tasks of CRO vendors
Qualifications & Certificates:
1. B.S. or M.S. degree in quantitative science disciplines, Statistics, pharmacy or related disciplines
2. Base SAS, SAS/STAT, SAS Graph and SAS Macro, Strong SAS programming skills, and other statistical and data processing software e.g. R/ Python.
3. Good oral and written communication skills in Chinese and English
4. At least 2-year experience in clinical data analysis
5. Ability to independently manage multiple tasks and projects
6. Familiar with CDISC standards(SDTM IG, ADaM IG, Define requirement)
7. Knowledge of clinical drug development process, and applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesStatistical Programming
职能类别:生物工程/生物制药
公司介绍
德琪医药有限公司(简称“德琪医药”,香港联交所股票代码:6996. HK)是一家专注于创新抗肿瘤药物的亚太地区临床阶段生物制药公司,德琪医药旨在为亚太地区及全球各地的患者提供全新作用机制的抗肿瘤创新疗法。自成立以来,德琪医药已建立起拥有12款临床及临床前创新药物的丰富产品管线,取得9个临床批件,并在亚太地区开展9项跨区域临床试验。公司在研产品专注于创新的靶点或作用机制,并拥有成为同类首款潜力的药物。德琪人以“医者无疆,创新永续”为愿景,力争通过对全球***和同类最优的专研与市场化,解决亚太乃至全球患者未满足的临床需求。
联系方式
- Email:Peter.Qian@antengene.com
- 公司地址:上海市长宁区中山西路1065号 中山SOHO 广场B 座 (邮编:200051)