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3-4年经验
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本科
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招2人
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02-04 发布
职位描述
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 dataCommunicate with statistician and medical manager to fully understand analysis requirements for assigned clinical projectsPerform all SAS programming tasks with high quality in the agreed timeline, and work closely with data management to assure data qualityParticipate 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 requiredKnowledge 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 membersAbility to work under pressure and manage multiple projects simultaneouslySolid analytical and problem solving skills paired with strong attention to detailExperience in CDISC, aCRF and XML is preferred Experience 2-6 years of related experience 职能类别: 临床数据分析员 关键字: 临床数据分析 SAS 统计编程
联系方式
黄陂南路838弄
公司信息
PPC佳生(Protech PharmaservicesCorporation)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,自成立以来,PPC佳生已为来自全球范围客户完成了2000多个早期临床研究项目(包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD);并且还执行了超过400个新药后期临床试验项目;所执行的研究方案涵盖24个疾病治疗领域。目前是亚太区域唯一通过日本PMDA、欧盟ANSM、东盟NCPB以及美国FDA核查的临床基地,生物样品实验室开发约300种药品分析方法,以丰富的执行经验提供海内外客户优质服务。2012年,PPC佳生于台北(McKay memorial Hospital)建立了第一家下属I期临床试验中心,并于2016年作为主要投资方与徐州医科大学资源共享,优势互补联合组建合作共同建立了徐州医科大学附属医院I期药物临床试验中心。
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