Senior Statistical Programmer
职位描述
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)
企业简介
公司简介:
国际精鼎科技股份有限公司(APEX International Clinical Research Co., Ltd. ), 成立于1996年,系协助世界各国大药厂从事新药开发及临床试验的临床研究委托机构(Contract Research Organization)。
国际精鼎临床试验研究团队是由一群具有丰富跨国性临床试验经验及专业知识的精英所组成,目前已成为亚洲地区规模最大、服务项目最完整之专业CRO公司,幷已在业界建立高品质的专业形象以及良好口碑。
APEX目前拥有超过300名的专业精英,服务遍及11个国家,在CRO的领域里已是亚洲的领导先驱。预计2007年APEX服务版图将再扩及2个国家、4个服务据点,人员也将扩增至500人。APEX重视与客户的承诺,更重视人才的培育和养成,我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境,期许同仁与公司一同成长,迈向未来。
主要服务项目:
新药开发策略的拟定与计划
国际临床试验规划及整合
引荐、甄选试验计划主持人
受试者同意书之设计
人体试验委员会之送审
最高卫生主管机关之送审
临床试验护理专员
临床研究数据处理
向亚洲地区卫生主管机关办理新药查验登记事务
中草药及健康食品临床试验、法规咨询及查验登记
愿景(Vision):创造一个在亚太地区具有国际竞争力的最精良CRO团队。
发展使命(Mission):
1 争取国际大药厂委托,执行符合国际水准的跨国性临床试验。
2 协助亚太生技及制药产业建立新药开发模式,以提升产品研发能力,幷促使产品国际化。
3 以提升临床试验品质为宗旨,拓展全球市场为目标,整合计算机及通讯科技,在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。
4 建立一个以亚洲人种高发生率疾病的基因数据库,以提供国际性新药研发机构所须之基因信息,协助其缩短药物开发时程,幷提高研发成功率。
福利制度:
.薪资:
1. 提供具竞争性之薪资(含车补及饭补)
.保险类:
1. 社会保险(依照国家规定)及住房公积金
2. 团体保险(包括寿险、意外暨医疗保险)
.制度类:
1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣,设计符合其个人之生涯规划
2. 完整的教育训练:每年公司均针对所有员工,提供完整之教育训练
3. 顺畅的升迁管道及可转调其它部门;如有职缺,亦可申请调至海外各子公司
.请 / 休假制度:
1. 服务第一年即享有9天特休, 后续年休假天数则依据服务年资及公司制度而定
2. 一年可享4天不扣薪病假
上海相关职位: 销售三部总监/副总监(医保/自费药招商)
热门区域招聘: 重庆 北京 上海 浙江 江苏 广东 山东 湖南 安徽 河北
上海招聘企业: 上海信谊药厂有限公司 上海强生制药 欧姆龙健康医疗(中国)有限公司 青海瑞成药业(集团)有限公司 上海交通大学医学院附属瑞金医院 复旦大学附属中山医院 上海复星医药 上海医药集团 上海脉启科技有限公司 上海现代哈森(商丘)药业有限公司
职位发布日期: 2016-12-09