上海招聘

o    Provide effective leadership and direction to the project team to achieve the business objectives and goals

o    Ensure the project is completed within budget, schedule and according to contract specifications and adhere to

      quality standards, SOPs, ICH and/or other guidelines and regulations

o    Determine the cause of project overruns, recommend and institute corrective action, with input from functional

       experts, escalate and follow-up as appropriate

o    Ensure maintenance of SA project documentation on an ongoing basis throughout the course of a project

o    Prepare, participate in and follow up audits/inspections

o    Effectively communicate with internal and external customers as well as third party vendors and clients

o    Provide input to proposals and attend Bid Defense meetings as required

o    As needed, participate in a meeting with Business Development to understand the scope of the contract and any

       Master Service Agreement in place for the client

o    Provide Performance feedback and mentor team members

o    Prepares analysis plans and writes detailed specifications for analysis files, consistency checks, tables and figures

o    Support clinical study report writing

o    Support other department by providing statistical expertise for issues in clinical research

o    Support Business Development

o    Sample Size Calculation

o    Update knowledge in statistical concepts, methods and techniques

o    Communicates with Clients regarding statistical analysis issues

o    Verify statistical programs, statistical results and data sets used in statistical section of technical documents

o    Performs quality control procedures on SAS programs

o    Mentors other programmers regarding processes, best practices and techniques

o    Co-operate in further development of internal manuals and SOPs

o    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 documents

任职要求：

o    Bachelor’s degree in Statistics, Science or industry-related discipline

o    5 years substantial and related experience in statistics in clinical research

o    Ability to apply statistical methodology to well-formulated problems in the clinical research field

o    Extensive experience in people management

o    Good understanding and experience in the clinical trial process

o    Strong knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations standard environment

o    Understanding of the needs and use of data standards (CDISC, HL7) in the clinical trial environment

o    Familiar with the application of SAS programming  and related systems and software, excellent computer skills

and proficient in Microsoft Word, Excel and PowerPoint

o    Focus on quality and detail 

o   Good communication skills and must be fluent in both written and spoken English or Japanese 

o    Good team player with excellent interpersonal and organizational skills 

o    High integrity in personality and professionalism 

o    Positive attitude, high degree of initiative, committed and able to work independently 

o    Self-initiative to perform duties, with good analytical and problem-solving capabilities

o    Ability to handle multiple and varied tasks with enthusiasm, prioritize workload with attention to detail

o    Meticulous and able to work in a fast-paced environment 

o    Able to work under pressure and under challenging timelines when required

o    Ability to travel as required

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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