[上海]上海百利佳生医药科技有限公司

公司官网:ww***com[点击查看] 专业1:统计学 职能类别:临床数据分析员

  

Background

  

Protech Pharmaservices Corporation (PPC) was founded in 1997 to meet the growing demands for R&D outsourcing from the Pharmaceutical and Biotech industries in the Asia- Pacific region. PPC is the largest CRO in Taiwan to offer a complete range of Clinical Research and Contract Laboratories services. In order to build up an international CRO network, PPC has formal alliances in Japan. In addition, PPC has branch operations in China (Beijing, Shanghai), Japan, and Korea.

  

Responsibilities

  

• Development and documentation of programs used in the production of computer generated outputs for clinical study reports, registration and submission documents, publication requirements plus any other document used to present clinical trials data

• Communicate with statistician and medical manager to fully understand analysis requirements for assigned clinical projects

• Perform all SAS programming tasks with high quality in the agreed timeline, and work closely with data management to assure data quality

• Participate in review of protocol, statistical analysis plan (SAP), data management plan (DMP) and case report form (CRF)

• Preparation of electronic submission of clinical data

          

  

Education/Qualifications

  

• BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation

• In-depth knowledge of Base SAS, SAS/STAT, SAS Graph, SAS SQL and SAS Macro Language. SAS Certification is preferred, not required

• Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH-GCP etc.)

• Effective communication skills and ability to establish and maintain effective working relationships with study team members

• Ability to work under pressure and manage multiple projects simultaneously

• Solid analytical and problem solving skills paired with strong attention to detail

• Experience in CDISC, aCRF and XML is preferred

              

  

  

公司名称:上海百利佳生医药科技有限公司 公司类型:外资（欧美） 公司规模:150-500人 公司介绍:PPC佳生（PPC Group）成立于1997年，致力于为国内外制药企业及生物技术公司提供专业化临床研究服务，为中国大陆、中国台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自1997年至今，PPC佳生已经完成了超过2000项早期临床试验项目，其中包括创新药I期研究、仿制药生物等效性研究以及生物类似药早期临床研究（包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD）。同时，PPC佳生也已经完成超过400项II期至IV期临床试验项目，其中涉及24个主要研究领域。目前PPC佳生是亚太区域唯一通过中国台湾TFDA,日本PMDA,法国ANSM，东盟NPRA，美国FDA以及中国CFDA核查的临床基地。   2012年，PPC佳生于台北（MacKay Memorial Hospital）建立了第一家下属I期临床研究中心；2017年初作为主要投资方与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心；2018年，PPC佳生又分别与徐州市中心医院，鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。 工作时间：周一到周五9:00-18:00（弹性工时） 年假：第一年15天，每加一年加1天，20天封顶 带薪病假：5天 五险一金：按基本工资作为基数，足额缴纳 试用期工资：100%发放，与转正一样