药物临床试验之生物统计经理
上海恒瑞医药有限公司
- 公司规模：500-1000人
- 公司性质：合资(非欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2016-10-21
- 工作地点：上海-浦东新区
- 招聘人数：1人
- 工作经验：1年经验
- 学历要求：硕士
- 职位月薪：10000-40000/月
- 职位类别：临床数据分析员
职位描述
职位描述：
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? 统计学相关专业硕士
? 制药企业1-3年临床试验经验
PESPONSIBILITIES
? Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data-handling rules and mockups
? Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.
? Produce tables, listings and figures; perform data review and statistical analysis.
? Advise data management staff on database design, and critical data and data quality review.
? Write statistical sections in protocol or integrated reports within assigned projects
? Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information ?
? Independent peer review or QC of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports ? SAS programming and related activities for the presentation and analysis of clinical trial data
? Provide support for special committees, e.g., DMCs including input/review of charters, and ensuring maintenance of appropriate blinding
?负责统计分析计划，包括统计方法，统计编程程序，导出的变量，数据处理规则和实体模型的定义的发展
?协助协议开发，样本量计算，方案和病例报告表（CRF）的审查。
?制作表格，列表和数字;进行数据审查和统计分析。
?在数据库设计和关键数据和数据质量审查提供咨询的数据管理人员。
?写在协议的统计部分或分配项目中集成的报告
?准备随机指标;生成的时间表;随机验证组件（规格及时间表）。提供投入相关的准备，分发和获取随机和揭盲信息?规划活动
?独立的同行评审或质量控制的统计成果，例如，协议，统计分析计划，表格，图形和患者数据信息，统计报表，临床研究报告?SAS编程及相关活动的临床试验数据的介绍和分析
?提供专门委员会支持，例如，发展中成员体包括宪章的输入/检讨，以及在适当的致盲确保维修
Education
? PhD in biostatistics or related field; Master's degree in biostatistics or related field and 3 year relevant experience
? 统计学或相关专业硕士; 制药企业1-3年临床试验经验
Experience
? Strong statistical experience in oncology trials is required
? Excellent written and oral communication skills including grammatical/technical writing skills
? In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
? Working knowledge of relevant Data Standards (such as CDISC/ADaM)
? SAS proficiency including use of a variety of statistical procedures e.g. non-parametric analysis, linear and non-linear models, categorical data and survival analysis ?
? Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc
?在肿瘤试验强的统计经验是必需的
?优秀的书面和口头表达能力，包括语法/技术写作技巧
?在深入了解适用的临床研究的监管要求;也就是说，药品临床试验管理规范（GCP）和国际协调会议（ICH）的指引熟悉适用于适用的临床试验比较复杂的统计方法
?有关数据标准（如CDISC/亚当）的工作知识
?SAS能力包括运用各种统计方法，例如非参数分析，线性和非线性模型，分类数据和生存分析?
?在统计分析计划的编制经验，分析，报告等
职能类别： 临床数据分析员
公司介绍
上海恒瑞医药有限公司系江苏恒瑞医药股份有限公司的全资子公司，注册资本7200万元，前期建设投资1.8亿元。公司设位于上海闵行经济技术开发区内，其中研发中心占地10053.53平方米，于2004年5月投入使用。在科研开发方面，公司将瞄准国际先进水平，建立科研基础平台，积极拓展新药研发领域，增加产品剂型，填补国内空白，参与国内国际市场竞争，提高民族医药工业水平。整个研发中心致力于创新药物的发现，以极大的热情向社会提供以科研开发为基础，适合市场需求的高科技医药产品。
为什么要选择上海恒瑞？为什么上海恒瑞一定成功？
***，我们拥有雄厚的资本，决意发明新药，并且已作巨额投资；第二，我们已有丰富的临床和市场发展经验，从实验发明到投入市场的时间大量减少；第三，有能力从目标化合物设计合成，体外体内筛选，药代毒理，药理到GMP生产完全自办；第四，我们拥有一支经验丰富的新药发展团队，融入其中的每位员工都可以增加新药发明过程的经验；第五，我们聘请***的人才，采用先进的生物工程管理方法，以工作表现为基础的薪金奖金制度、活动工作时间以及无上限研究级别升级；第六，我们拥有先进的实验设施—无任务上限的Scifinder的化学信息库等，我们拥有绝对无烟的工作环境，而且先进的实验设备也为我们创造了一个无噪音、无气味的健康环境；第七，我们从事的是真正的有知识产权的新药研发，而不是生产中间体。
Discovering drugs not making intermediates
Shanghai Hengrui Pharmaceuticals Co. Ltd. is a fully integrated drug discovery company with marketed products well funded by a top Chinese pharmaceutical company dedicated to discovery of IP protected New Chemical Entities (NCEs). We are conveniently located in Minhang Economic Zone, 30 minutes from the vibrant Shanghai downtown and occupy a new 10,000 square meter. laboratories equipped with state-of-art instruments. We are currently recruiting scientists in all areas of drug discovery.
We offer a locally competitive compensation and benefits package and provide a highly interactive, open, challenging, smoke-free and campus-like environment. We have also adopted a performance based award system and created a scientific ladder for dedicated and motivated individuals to grow within the company. If you are interested in joining this new drug discovery revolution in China, please forward your resume to Miss Hong (career@shhrp.com) for immediate consideration. Applicants from other areas of drug discovery are also invited to send in their CVs.
为什么要选择上海恒瑞？为什么上海恒瑞一定成功？
***，我们拥有雄厚的资本，决意发明新药，并且已作巨额投资；第二，我们已有丰富的临床和市场发展经验，从实验发明到投入市场的时间大量减少；第三，有能力从目标化合物设计合成，体外体内筛选，药代毒理，药理到GMP生产完全自办；第四，我们拥有一支经验丰富的新药发展团队，融入其中的每位员工都可以增加新药发明过程的经验；第五，我们聘请***的人才，采用先进的生物工程管理方法，以工作表现为基础的薪金奖金制度、活动工作时间以及无上限研究级别升级；第六，我们拥有先进的实验设施—无任务上限的Scifinder的化学信息库等，我们拥有绝对无烟的工作环境，而且先进的实验设备也为我们创造了一个无噪音、无气味的健康环境；第七，我们从事的是真正的有知识产权的新药研发，而不是生产中间体。
Discovering drugs not making intermediates
Shanghai Hengrui Pharmaceuticals Co. Ltd. is a fully integrated drug discovery company with marketed products well funded by a top Chinese pharmaceutical company dedicated to discovery of IP protected New Chemical Entities (NCEs). We are conveniently located in Minhang Economic Zone, 30 minutes from the vibrant Shanghai downtown and occupy a new 10,000 square meter. laboratories equipped with state-of-art instruments. We are currently recruiting scientists in all areas of drug discovery.
We offer a locally competitive compensation and benefits package and provide a highly interactive, open, challenging, smoke-free and campus-like environment. We have also adopted a performance based award system and created a scientific ladder for dedicated and motivated individuals to grow within the company. If you are interested in joining this new drug discovery revolution in China, please forward your resume to Miss Hong (career@shhrp.com) for immediate consideration. Applicants from other areas of drug discovery are also invited to send in their CVs.
联系方式
- Email：career@shhrp.com
- 公司地址：地址：span上海市闵行经济开发区文井路279号