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药物临床试验之生物统计师

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  • 硕士
  • 三年以上
  • 卫生统计学
  • 面议
  • 上海市浦东...
  • 2017-02-09

上海恒瑞医药有限公司

类型:医药企业 / 一万人以上

地址:东方路778号紫金山大酒店12楼

该单位 HR 近两周的应聘简历处理率: 21%

职位描述

• 生物统计学或相关专业博士; 生物统计学硕士;
• 相关专业3年以上工作经验.

PESPONSIBILITIES
• Responsible for development of Statistical Analysis Plans, to includestatistical methodology, statistical programming procedures, definitionof derived variables, data-handling rules and mockups
• Assist with protocol development, sample size calculation, protocoland case report form (CRF) review.
• Produce tables, listings and figures; perform data review andstatistical analysis.
• Advise data management staff on database design, and critical data anddata quality review.
• Write statistical sections in protocol or integrated reports withinassigned projects
• Prepare randomization specifications; generate schedules; verifyrandomization components (specification and schedule). Provide inputinto planning activities related to the preparation of, distribution ofand access to randomization and unblinding information •
• Independent peer review or QC of statistical deliverables, e.g.,protocols, Statistical Analysis Plans, Tables, Figures and Patient DataListings, statistical reports, Clinical Study Reports • SAS programmingand related activities for the presentation and analysis of clinicaltrial data
• Provide support for special committees, e.g., DMCs includinginput/review of charters, and ensuring maintenance of appropriateblinding
•负责统计分析计划,包括统计方法,统计编程程序,导出的变量,数据处理规则和实体模型的定义的发展
•协助协议开发,样本量计算,方案和病例报告表(CRF)的审查。
•制作表格,列表和数字;进行数据审查和统计分析。
•在数据库设计和关键数据和数据质量审查提供咨询的数据管理人员。
•写在协议的统计部分或分配项目中集成的报告
•准备随机指标;生成的时间表;随机验证组件(规格及时间表)。提供投入相关的准备,分发和获取随机和揭盲信息•规划活动
•独立的同行评审或质量控制的统计成果,例如,协议,统计分析计划,表格,图形和患者数据信息,统计报表,临床研究报告•SAS编程及相关活动的临床试验数据的介绍和分析
•提供专门委员会支持,例如,发展中成员体包括宪章的输入/检讨,以及在适当的致盲确保维修

Education
• PhD in biostatistics or related field; Master's degree inbiostatistics or related field and 3 year relevant experience
• 生物统计学或相关专业博士; 生物统计学硕士; 相关专业3年以上工作经验.

Experience
• Strong statistical experience in oncology trials is required
• Excellent written and oral communication skills includinggrammatical/technical writing skills
• In-depth knowledge of applicable clinical research regulatoryrequirements; i.e., Good Clinical Practice (GCP) and InternationalConference on Harmonization (ICH) guidelines Familiarity with moderatelycomplex statistical methods that apply to applicable clinical trials
• Working knowledge of relevant Data Standards (such as CDISC/ADaM)
• SAS proficiency including use of a variety of statistical procedurese.g. non-parametric analysis, linear and non-linear models, categoricaldata and survival analysis •
• Experience in the preparation of Statistical Analysis Plans, analysis,reporting, etc
•在肿瘤试验强的统计经验是必需的
•优秀的书面和口头表达能力,包括语法/技术写作技巧
•在深入了解适用的临床研究的监管要求;也就是说,药品临床试验管理规范(GCP)和国际协调会议(ICH)的指引熟悉适用于适用的临床试验比较复杂的统计方法
•有关数据标准(如CDISC/亚当)的工作知识
•SAS能力包括运用各种统计方法,例如非参数分析,线性和非线性模型,分类数据和生存分析•
•在统计分析计划的编制经验,分析,报告等

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