临床试验统计师 Bio statistician 上海

月薪： 1.5-2.4万/月

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

职位描述

职位描述： 职位描述：Job Overview:Provides all biostatistical services to meet the requirements of all CPWW clients, including full-service, Bioinformatics, and other type studies.职责描述：?Keep internal Biostatistics and Statistical Programming folders up to date with relevant study documentation.?Develop Statistical Analysis Plans (SAP), mock-up tables, programming and derived dataset specifications.?Determine study randomization scheme from protocol and assume responsibility for providing a correct Randomization Specification for the study.?Provide oversight of programming and QC of derived datasets and Tables, Figures and Listings (TFL) in close cooperation with Statistical Programming.?Lead data review to ensure clean data and proper evaluation and identification of all major protocol deviations prior to database lock.?Provide all statistical analyses as needed.?Write the statistical section of the Clinical Study Report (CSR) and collaborate with Medical Writing in preparing the integrated CSR.?Assume responsibility for writing a Statistical Report as needed.?Support protocol development including experimental design, randomization, sample size calculation, statistical methods, define study objectives and endpoints. Provide input on potential biostatistical implications on study design, conduct, and analysis of protocol amendments.?Design of data integration concepts.?Collaborate with Data Manager by reviewing study Data Management Plan (DMP), electronic case report forms (eCRFs) and edit check specifications.?Attend internal and client-facing meetings.?Assume responsibility for maintaining the statistical portion of the Trial Master File.?Monitor study Biostatistics budget and report update to PM, regional Director of Biostatistics, and Director of Statistical Programming when budget limit is being reached.?Monitor study Biostatistics timelines to ensure all are being met and that Units and Milestones (U&Ms) trackers are being recorded in a timely manner.?Service IDMC/DSMB statistical requirements and attend their meetings as needed.?Serve as interface between client and internal teams as needed, relay relevant information to appropriate client and internal stakeholders. Other duties commensurate with the position as assigned by line manager任职要求：?EducationoPhD or Master’s in statistics or related area, equivalent degree or working experience.?ExperienceoExperience in CRO or pharma/biotech industry experience will vary, could be none for certain positions.oRelated experience in academia or regulatory could be considered.?Skills/CompetenciesoInterpersonal and communication skills. Good written and oral communication skills including technical writing of statistical resultsoAble to effectively handle multiple tasks and projects. Able to organize workflow and manage time effectively. Ensures tasks are completed accurately, on time and within budget.oTeam player, shows teamwork, cooperation, self-control, and flexibility to get the work done. Is comfortable working independently with some supervision and as part of a team.oPractices professionalism and integrity in all actions. Demonstrates honesty, trust and fairness.oFluency in English, orally and in writing.?CapabilitiesoKnowledge of statistics: Working knowledge of moderately complex statistical methods commonly used in clinical trials. For example, experimental design, categorical data analysis, ANOVA, ANCOVA, repeated measures analysis, MIXED models, survival analysis and non-parametric methods.oStatistical Quality: Reviews and monitors quality of statistical tasksand project deliverables provided by statistical project team.oKnowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language. Preferred familiarity with other computing packages such as Splus, R, WinBugs, PASS, etc.oKnowledge of clinical drug development process.oKnowledge of phases of clinical trials and relevant statistical considerations that apply to Phase I-IV studies.oKnowledge of GCP and ICH guidelines and other regulatory guidelines related to statistics.oGood training and presentation skills: Has the ability to effectively communicate statistical concepts to non-statisticians.oUnderstanding of departmental and company procedures and SOPs which relate to tasks that are performed routinely.oKnowledge of Microsoft Office with several custom Windows based applications and programming software. 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

上海相关职位
猎才二维码