职位描述
职位描述: o Draft statistical selection of protocolo Review CRFo Develop statistical analysis plan and mock-up TFLso Develop analysis data set specificationo Review all tables, figures and listingso Prepares analysis plans and writes detailed specifications for analysis files, consistency checks, tables, and figureso Develop statistical analysis reporto Analyse and interpret data for clinical trialso Compiles reports, charts, and tables based on established statistical methodso Perform meta-analyses by pooling data from several studieso Support Clinical Study Report writingo Support other department by providing statistical expertise for issues in clinical researcho Support Business Developmento Sample Size Calculationo Update knowledge in statistical concepts, methods, and techniqueso Co-operate in further development of internal manuals and SOPso Participate in cross functional meetings and drive initiatives to ensure the delivery of milestones and timelines for clinical trialso Coordinate technical set-up for complex projects / programso Provide input to proposals and attend Bid Defense Meetings as requiredo Be trained in client SOPs and disseminate knowledge to the biostat project team members, as appropriate o Ensure all team members have access to tools and documentsrequirements:o Bachelor’s degree in Statistics, Science or industry-related disciplineo 3-5years substantial and related experience in statistics in clinical researcho Ability to apply statistical methodology to well-formulated problems in the clinical research fieldo Focus on quality and detailso Analytical expertise in understanding complex issues and their consequenceso Familiar with the application of SAS programming and related systems and software, excellent computer skills and proficient in Microsoft Word, Excel and PowerPointo Good communication skills and must be fluent in both written and spoken English or Japaneseo Good team player with excellent interpersonal and organizational skillso High integrity in personality and professionalismo Positive attitude, high degree of initiative, committed and able to work independentlyo Self-initiative to perform duties, with good analytical and problem-solving capabilitieso Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervisiono Meticulous and able to work in a fast-paced environmento Able to work under pressure and under challenging timelines when required 职能类别: 生物工程/生物制药
公司信息
CRO(Contract Research Organization)是指合同研究组织,为科研单位、制药企业的新药企业的新药开发提供临床试验的企划、运筹等一系列专业服务。随着GCP的运行、新药开发的国际化、特别是在欧美日本等先进国家,CRO以其极强的专业性、中立性、在新药开发中发挥着愈来愈重要的作用。
日本 EPS 株式会社( EPS Co., Ltd. )创业于1991年,是日本CRO领域起步早?规模大的CRO企业。2001年7月在日本东京证券市场成功上市,开创了CRO在日本上市的先例。 EPS集团在25年间有了迅速发展,目前已发展成为一个拥有30余家公司,其中两家日本上市企业,近4000员工覆盖全球各区域的跨国集团公司。
上海日新医药发展有限公司是EPS于2001年登陆中国市场,最早引入合同研究组织 (CRO)在华业务的公司。主要从事新药的I到IV期临床试验设计、实施、数据管理、统计分析和分析报告制作等业务,同时开展新药的注册、申报、医药咨询以及市场调研等业务。
本公司于2001年7月在上海正式注册成立,并在北京、广州设有分支机构。现公司设有业务开发、临床开发、注册事务、数据管理、统计分析、市场调查等部门。
凭借在日本从事CRO业务多年的经验,和EPS集团在日本、美国、中国大陆、中国台湾、新加坡等国家和地区的分公司和代表处的雄厚实力,日新公司成长为国内合同研究组织(Contract Research Organization)行业的领军者之一。我们基于中国,面向亚太地区,全面开展全球性的临床研究代理业务。
网址: http://www.eps.co.jp;http://www.epsi-global.com
福利制度介绍:
一 保险类:
1. 养老保险
2. 医疗保险
3. 失业保险
4. 工伤保险
5. 生育保险
6. 住房公积金
7. 补充医疗保险
8. 意外伤害保险
二 制度类:
1. 完整的教育训练
2. 透明化并顺畅的升迁管道
3. 生涯发展规划
4. 多元的海外工作机会
-请/休假制度:
1. 周休二日
2. 年假9-15天/年
3. 入职每满3年, 给予额外的5天长期服务休假奖励
三 其它:
1. 节庆礼品, 生日补贴,
2. 健康体检项目
3. 饭贴, 交通/通信补贴
4. Team Building活动及补助
5. 完善舒适的办公室环境及设备
6. 畅通的沟通渠道和和谐的团队
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