临床统计程序师Statistical Programmer 上海

月薪： 0.8-1.5万/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 通讯补贴
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： Job Overview:The Statistical Programmer II is responsible for programming activities for the data preparation and analysis of clinical data with medium to high complexity. Duties include creation of datasets, tables, listings and figures according to the project specifications as well as coordination of Quality Control efforts and implementing all programming required for study/project completion.职责描述：Job Duties and 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, e.g. answers to requests from health authorities, individual sponsors requests, scientific papers and conferences, etc. in line with existing regulatory guidelines, industry standards and standard operating procedures issued by Clinipace and/or clients as appropriate.o Conception and generation of dataset specificationso Design of integrated databases and development of mapping specifications for integrated datasetso Development and documentation of programs used to generate datasetso Development and documentation of programs used to generate listings, tables and graphso Program validation including generation of validation documentationo Data preparation and documentation according to CDISC data standards?Preparation of electronic submission of clinical data?Intense and cross functional interaction with other members of the project team?Providing internal consultancy in various review activities like database design, data validation rules, analysis plans, table shells etc.?Interaction with clients?Design, development, documentation and validation of tools and macros to continuously improve quality and efficiency of processes applied?Writing of User Manuals?Training of group members on new processes, programs etc. as appropriate?Initial Training on existing processes, programs etc. for new group members?Attending and representing the company at business conferences?Coordination of allocated teams of Statistical Programmers assigned to a specific client project including the monitoring of workload, estimation and forecast of resource needs within the specific activity and responsibility for coaching and education of other team members.任职要求：?Educationo BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation?Experienceo Minimum of 4 years’ experience in processing and analyzing clinical trial data or demonstrated aptitude for statistical programming worko ＞ 3 years’ practical experience in the use of a statistical software package (like SAS or R) with respect to all aspects of software development and validation?Skills/Competencieso Highly developed analytical skills, team player qualities (knowledge, skills, personal qualities)o Fluency in Englisho Sound knowledge of the SAS programming languageo Knowledge of relevant regulatory requirementso Knowledge of medical terminology and conduct and analysis of clinical trialso Knowledge of industry data standards (e.g. CDISC SDTM and ADaM)?Capabilitieso Team player: Shows support for teamwork, cooperation, self-control, and flexibility to get the job done.o Comfortable working under supervision and as part of a team.o Practices professionalism and integrity in all actions.o Demonstrates honesty, trust and fairness.o Strong written and verbal communication skills 职能类别： 生物工程/生物制药

联系方式

上海

公司信息

In Jan 2014,Choice Pharma(丘以思(上海)医药信息咨询有限公司) merged with Clinipace Worldwide. Clinipace Worldwide is a global full-service digital contract research organization (dCRO) that has pioneered an innovative service model to transform drug and medical device development by delivering technology-amplified services to improve study performance, collaboration, and transparency across all stakeholders. From managing your entire development program to conducting an individual clinical trial, our experts bring extensive therapeutic and local experience in building a well-defined clinical plan to maximize your success. Powered by TEMPO? – our proprietary eClinicaltechnology – our teams ensure your success and bring unsurpassed efficiency, quality, and visibility to your development programs. Now Clinipace Worldwide ranks the 10th CRO,and developes rapidly. Clinipace Worldwide，一个基于科技的全球性全方位服务的数字化合同研究组织（dCRO）。我们开创性的开发了依靠技术创新的CRO服务模式，以满足风险投资支持的，中型的战略性制药，生物技术公司以及医疗器械公司的研发需求。 借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。 Clinipace Worldwide的唯一目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。 我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，肾脏，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。 Clinipace Worldwide刚刚庆祝了他们的10週年。如今，Clinipace Worldwide其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。 因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace Worldwide还在持续的在全球扩张。 https://www.clinipace.com 最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入. 应聘邮箱：mwang@clinipace.com

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