上海招聘

Senior Statistical Programmer is responsible and accountable for executing SAS programming for multiple Phase I-IV clinical trials at a trial level, ensuring high quality and timely production of statistical reporting deliverables (tables, listings and graphs).

1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy, DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications).

2. Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files).

3. Develop or monitor the content and structure of SAS data sets.
SDTM and ADaM technical knowledge required. In addition, knowledge of agency requirements including ICH, FDA, CFDA and other guidances is strongly recommended.

4. Good understanding with different phases of clinical trials, protocols, and CRF designs. Providing input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents

5. Working independently as well as in teams to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process.

任职资格

Qualification

1. 数学、统计学、医药统计学、计算机或者相关领域的专业本科、硕士。
Bsc/ Msc in mathematics, statistics, medical statistics, computer science or related field.

2. 在医疗环境或者相关统计应用领域作为统计编程（SAS）人员的经验至少3年相关经验，

Minimum 3 years' experience in SAS programming in biostatistics department environment for phase I-IV clinical trials in a pharmaceutical/CRO environment.

3. 熟练使用 SAS编程语言包括SAS-Base, MACRO, STAT, GRAPH, ACCESS ETC

Strong skill in SAS programming, using SAS-Base, MACRO, STAT, GRAPH, ACCESS, etc.

4. 熟悉CDISC, SDTM and ADaM 标准

Knowledge of CDISC, SDTM and ADaM standards.

罗欣药业集团股份有限公司（以下简称“罗欣药业”）是集药品研发、生产、贸易和医疗健康服务为一体的大型医药企业集团。罗欣药业自2006年开始连续进入中国制药工业百强企业，自2011年连续被评为中国医药研发产品线***工业企业，是国家重点高新技术企业、国家技术创新示范企业、全国工业质量标杆企业。
罗欣药业专注于自主创新，已有200余项产品技术获国家发明专利证书；多次获得国家科学技术进步二等奖、省科学技术进步一等奖等国家和省部级荣誉；多个产品被列入“国家重点新产品计划”、“国家火炬计划”、“重大新药创制”等科技重大专项。在中国山东、上海等地均建有生产研发基地，现有员工7000余名。
罗欣药业坚持诚信为本、开拓创新的指导思想和“回报员工、回报客户、回报股东、回报社会、固强企业”的价值观，不断为患者创造***的所需价值空间，坚持以优质的产品、优惠的价格、优良的服务回馈社会。