武汉招聘

Job Summary

Provide timely support to the study on all programming matters according to the project/study plan.

Major Responsibilities

• Provide the programming support to clinical data analysis, eg. SDTM, ADaM, TLGs, etc.
• Follow specifications and requirements to produce datasets and TLFs under guidance.
• Perform quality control, as required per SOPs, for statistical programming deliverables.
• Perform programming activities for statistical deliverables within a project/study, eg. MDR, CSR, CTD, IB, DSUR, ISS, ISE etc.
• Work with study biostatistician and project lead to develop or review programming specifications.
• Develop programs to produce analysis datasets, tables, listings, and graphs according to specifications.
• Provide items required for submission (i.e. SAS transport files, define.pdf, annotated CRF).
• Performs ad-hoc analysis as request.
• Participate in department working groups, e.g. for the development and testing of department tools.
• Produce the datasets (eg. SDTM, ADaM) and TFLs independently.
• Manage and maintain programs, programming documents, and deliverables.

Qualification

• B.S. or M.S. degree in Statistics or related disciplines, with at least 2-year experience in clinical study analysis.
• Strong SAS programming skills, and other statistical and data processing software e.g. R.
• Understand the clinical trial, protocol, CRF, SAP etc.
• Understanding database concepts and data collection, analysis processes in clinical trial.
• Familiar with industry guidelines and standards, eg. CDISC standards, ICH guidelines.
• Good oral and written communication skills in Chinese and English.
• Able to work effectively with people from different functional background.
• Proactive and motivated.
• Good attention to detail to ensure accuracy and reliability of results.

                                    

全球知名生物医药企业资深研发团队打造的创新服务公司。让你的职场起点更高，更充满挑战和精彩。
 
我们是谁？
 
    基于中国面向全球制药，生物技术和医疗器械公司的临床开发服务和解决方案提供商:
· 临床试验全程及专业领域服务：临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理
· 战略咨询服务：临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。
 
为什么选择我们？
 
· 缔脉定位于以高品质服务和专业精神成为业界典范。
· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。
· 缔脉致力于通过系统培训，研发实践和开放式文化培养新一代生物药物研发国际化人才。
 
创始人及部分核心专业领域


创始人 - 谭凌实博士：拥有20多年跨国一流制药公司总部高级管理经验。此前担任辉瑞公司全球药物开发运营副总裁，在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点，成为辉瑞全球核心的研发中心之一，承担药物临床开发、安全风险管理、注册、临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作，比如复旦大学、北京大学，交通大学。培养了不少拥有专业技能和行业知识的临床数据管理和编程人才。谭博士有在美国建立初创企业的经验，且在美国一流制药企业研发中心工作多年。谭博士拥有生物统计博士学位。