发帖
雷达卡
Position Description:
The Biostatistician performs biometrics and SAS programming activities for all clinical trials involving drugs biologics and devices, and oversees the activities of programming and biostatistician consultants.
Responsibilities Include:
·Develops statistical section in clinical trial protocols
·Consults in study design, analysis strategies for interim, final report and ISS/ISE
·Performs sample size and statistical power calculations
·Generates randomization schedule according to the protocol
·Develops Statistical Analysis Plan with input from project team and sponsor per SOPs
·Reviews Statistical Analysis Plans created by Biostatisticians at GMCS or its consultants and provide guidance
·Supports DSMB and CEC committee regarding to statistics analysis
·Consults on other statistical tasks, such as support for CRFs development and study report writing
·Performs SAS programming to generate tables, listings, figures, and statistical analyses
·Oversees validation and quality assurance aspects of all Biostatistics and SAS programming activities
·Ensures the adherence to timelines for the Biostatistical and SAS programming aspects
·Supervises, coaches, and develops staff
·Reviews and revises SOPs and WPDs pertaining to Biostatistics and SAS Programming, consistent with FDA/SFDA and ICH regulations and guidelines
·Other relevant duties assigned for which the incumbent is qualified.
Education and Experience：
·MS degree in medical statistics or above, Ph.D preferred.
·Minimum 3 years of pharmaceutical statistics and/or statistical programming experience applied to drug or medical device development
·Demonstrated skills in planning, managing and coordinating biostatistics and SAS programming activities in clinical trials
·Demonstrated ability to deal with sensitive inquiries or complaints from clients or potential clients and to protect confidentiality
·Excellent team-building skills and the ability to work successfully in a team environment requiring matrix management skills
·Ability to make effective presentations in public settings
·Good command of English language and communication skills.
盖博医药信息咨询服务（上海）有限公司
Global Medical Consulting Services (Shanghai) Co., Ltd. (GMCS) is a wholly owned subsidiary of US-based Global Research Services, LLC (GRS). GRS has offices also in Canada, Germany, Poland, Britain, Brazil and India. GMCS is a leader in the management of clinical research programs for the pharmaceutical, biotech, and medical device communities. The company provides a full range of consulting and clinical trial management services that include protocol design, project management, data management, clinical site monitoring, biostatistical analysis, and medical report writing.
盖博医药信息咨询服务（上海）有限公司是一家国际性临床研究公司（CRO），总公司盖博研究服务有限公司（GRS）位于美国马里兰州罗克维尔市，并在加拿大、德国、波兰、 英国、巴西、印度以及中国设有分公司。作为GRS在中国注册全资子公司，盖博医药坐落于上海南京东路步行街黄浦商业圈。自1998年运营以来（前身为美国美迪范国际公司），盖博医药一直为全球的药厂、生物科技企业和医疗器械研发公司提供世界一流的临床试验及管理服务，包括临床管理、药物安全性管理、数据管理及生物统计支持等。
我们在世界各地与经验丰富的临床研究者及研究基地建立了广泛的联系网络，使得盖博能够为客户提供多种临床研究方案。
我们始终坚持高品质服务，在中国的本土团队也同样遵循ICH、GCP、FDA的工作标准，严格执行总公司的操作流程及客户所要求的操作规范。通过盖博在世界各地的分支机构的密切合作，有效保证了公司全球信息网络、信息基础架构、应用程序、通讯线路和备份系统符合FDA 21CFR11的要求。盖博医药曾多次接受并通过了诸多国际大药厂的审核，并有幸成为第一批通过中国国家食品药品监督管理局核查并获得高品质赞誉的临床研究合同委托公司（CRO）。
多年的积累，多年的奋斗，成就了今日盖博的辉煌和底蕴。总公司正在进一步加大在中国的投资和致力于中国团队的建设，盖博医药的目标是要成为员工和客户的最佳选择。
京公网安备 11010802022788号
