作为中国领先的提供全方位专业服务的临床研究组织,依格斯(北京)医疗科技有限公司于1999年注册成立。公司提供与药品临床开发相关的一系列专业服务,包括产品注册、项目管理、I-IV临床试验和国际多中心临床试验的监查、受试者招募、数据管理、生物统计和咨询。
依格斯的总部位于北京,在上海、广州、南京、成都、重庆、沈阳、南宁、武汉、西安、哈尔滨等城市设有办事处或服务网点。在美国和欧洲市场,依格斯已在陆续建立代表处。
基于为客户提供的优质服务,依格斯在国际前50名的跨国及国内优秀的制药公司中树立了良好的声誉。同时,依格斯与政府部门、工业界、医院、研究机构保持着广泛的接触和紧密的联系。
迄今为止,依格斯在40个城市的约130家医院进行了123个I—IV期临床研究项目,涉及病人约25,000例。
中国市场吸引力的日益增强,以及依格斯团队专业化程度的不断提高,使我们对以后三年营业额的强劲增长和公司规模的持续壮大充满了信心。目前,依格斯拥有90多名优秀的员工,是中国国内规模最大的CRO公司。2008年年底前,预计员工数量将达250人。
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依格斯(北京)医疗科技有限公司 |
职位: Data Management & Statistics Director
- 硕士其以上学历,8年以上相关工作经验
- 5个月内到位
Responsibilities:
1.To plan, direct and implement all aspects of biostatistical analysis and support to the development of new products, domestic and international regulatory submissions in a given therapeutic area.
2.Direct statisticians and data management staff which provide leadership and support to multiple projects within a therapeutic area under the leadership of project leader.
3.Closely interact with the project managers to coordinate and deliver biostatistical support, consultation, and direction for this discipline in a therapeutic area and communicate results with department head.
4.Work with project data specialists and statisticians to ensure the validity and accuracy of the summary tables, graphs and data listings for the integrated statistical/clinical report.
5.Work with project leaders and medical writers to ensure the completeness and accuracy in the content of the integrated statistical/clinical report.
6.Work with all team members to develop and implement biostatistical support systems focused on meeting or exceeding project requirements.
7.Represent the company to interact with corporate partners on the biostatistical aspect of the product development for a given therapeutic area.
Qualifications:
1.Postgraduate Degree in public health or equivalent and at least 5 years of industry experience in clinical trial with at least 3 years direct staff management experience in CRO.
2.Strong management skills and experience managing projects in a CRO environment.
3.Familiar with all stages of data management from database setup up through final database lock; familiarity with in-depth knowledge of the statistical analysis procedures.
4.Organizational, leadership, decision making, and strong communication skills. 5.Fluent in spoken and written English.