Director, Statistical Programmer (职位编号:62939325)
云顶药业(苏州)有限公司
- 公司规模:50-150人
- 公司性质:外资(非欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-11-10
- 工作地点:上海-静安区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:80-100万/年
- 职位类别:生物工程/生物制药
职位描述
Key Responsibilities:
The candidate is expected to have proven solid technical skills in SAS programming for clinical drug development and reasonable people management experience. The key responsibilities of this role include but not limited to:
- Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data and for electronic regulatory submissions of data in CDlSC format
- Regularly works with advanced features of SAS including interfacing abilities with other software applications and operating system tools
- Collaborate efficiently and effectively with cross-functional team members on clinical trials, closely with statisticians to ensure timely deliverables with high quality, e.g. SDTM and ADaM datasets, statistical analysis results of clinical trials and integrated analyses cross trials
- Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, regulatory agencies, etc.) for projects with more significant consequences and impact
- Participates on high impact departmental and cross-functional teams working on standard operating procedures, process improvements, system validation, and acquisition, customization, and integration of new tools and technologies
- Support the Head of Biometrics to establish a high performing team of statistical programmers, supervise/mentor junior programmers
Recommended Education and Key Competency:
- Master degree or equivalent, preferably in a life science, biostatistics or other mathematics-related area, including computer sciences.
- 12+ years of experience in statistical programming in the pharmaceutical industry, oncology therapeutic area preferred
- Proven expert experience with SDTM and ADaM developments
- Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- Solid understanding of clinical drug development
- Understanding of relevant regulatory guidelines, GCP and industry standards and practices regarding data management
- Strong project management skills, problem-solving skills, conflict management skills
- Displayed highly developed organizational leadership qualities
- Strong English skills (both verbal and written)
职能类别:生物工程/生物制药
公司介绍
Our mission is to build a preeminent biopharmaceutical organization to develop and commercialize globally innovative products in Greater China and other emerging Asia Pacific markets.
Our advantage includes an insight-driven, highly productive business development engine and world-class clinical and regulatory teams, supported by a substantial financial foundation.
Our advantage includes an insight-driven, highly productive business development engine and world-class clinical and regulatory teams, supported by a substantial financial foundation.
联系方式
- 公司地址:地址:span国贸大厦