Senior Statistical Programmer
精鼎医药研究开发(上海)有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-07-15
- 工作地点:上海
- 招聘人数:5
- 工作经验:三年以上
- 学历要求:硕士
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:生物工程/生物制药
职位描述
The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might
act as an internal subject matter expert in specific areas providing technical support and expert advice,
and works independently to support various programming activities related to the analysis and
reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical
Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other
functional areas as required.
Key Accountabilities
??Deliver best value and high quality service
??Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming
Coordinator will:
o Input into and negotiate statistical programming timelines. Ensure that timelines are
adhered to.
o Coordinate and lead a statistical programming team to successful completion of a study
within given timelines and budget
o Monitor project resourcing, project budgets, and identify changes in scope
??Interact with Sponsors as the key contact with regard to statistical programming issues
??Provide technical support and advice to the internal team
??Check own work in an ongoing way to ensure first-time quality
??Ensure quality control (QC) on all process and technical activities related to derived dataset, table,
listing, and figure programming in accordance with corporate quality standards,
WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
Skills
??Proficiency in SAS
??Knowledge of the programming and reporting process
??Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other
applicable local and international regulations such as 21 CFR Part 11 and proven practical
application
??Demonstrate ability to learn new systems and function in an evolving technical environment.
??Strong leadership ability
??Attention to detail
??Ability to successfully work together with a (“virtual”) team (including international teams as
required) as well as independently
??Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to
change
??Business/Operational skills that include customer focus, commitment to quality management and
problem solving
??Good business awareness/business development skills (including financial awareness)
act as an internal subject matter expert in specific areas providing technical support and expert advice,
and works independently to support various programming activities related to the analysis and
reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical
Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other
functional areas as required.
Key Accountabilities
??Deliver best value and high quality service
??Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming
Coordinator will:
o Input into and negotiate statistical programming timelines. Ensure that timelines are
adhered to.
o Coordinate and lead a statistical programming team to successful completion of a study
within given timelines and budget
o Monitor project resourcing, project budgets, and identify changes in scope
??Interact with Sponsors as the key contact with regard to statistical programming issues
??Provide technical support and advice to the internal team
??Check own work in an ongoing way to ensure first-time quality
??Ensure quality control (QC) on all process and technical activities related to derived dataset, table,
listing, and figure programming in accordance with corporate quality standards,
WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
Skills
??Proficiency in SAS
??Knowledge of the programming and reporting process
??Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other
applicable local and international regulations such as 21 CFR Part 11 and proven practical
application
??Demonstrate ability to learn new systems and function in an evolving technical environment.
??Strong leadership ability
??Attention to detail
??Ability to successfully work together with a (“virtual”) team (including international teams as
required) as well as independently
??Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to
change
??Business/Operational skills that include customer focus, commitment to quality management and
problem solving
??Good business awareness/business development skills (including financial awareness)
公司介绍
精鼎医药(Parexel International)是全球领先的药物研究合同委托机构(CRO),总部位于美国生物医药圣地马萨诸塞州的波士顿附近,在世界各地拥有71个办事处,约17,600 名员工,为超过100个国家的客户提供服务。
精鼎医药成立于1982年,在三十多年的历程中,一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商,并且取得了卓越成果。目前,我们能够提供全世界CRO领域全面的新药临床阶段研发服务,服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。
将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案,可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。
精鼎医药成立于1982年,在三十多年的历程中,一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商,并且取得了卓越成果。目前,我们能够提供全世界CRO领域全面的新药临床阶段研发服务,服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。
将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案,可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。
联系方式
- Email:tony.feng@parexel.com
- 公司地址:上海市浦东新区商城路506号新梅联合广场B座9层 (邮编:200120)