上市前 - 助理临床生物统计师
恒瑞医药-上海盛迪医药有限公司
- 公司规模:10000人以上
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2022-06-26
- 工作地点:南京-鼓楼区
- 工作经验:无需经验
- 学历要求:硕士
- 职位月薪:1-1.5万
- 职位类别:医药技术研发人员
职位描述
【Job Description】:
1. Support sample size / power calculations and development of statistical section of the protocol;
2 Support to prepare Statistical Analysis Plan (SAP), including the resulting tables, figures, and listings for inclusion in the Statistical Analysis Report (SAR), clinical study report (CSR) and/or publications;
3 Support to develop SAS program for planned or ad hoc analyses and to prepare data displays;
4 Provide support on verification of statistical programs, data sets used and statistical results in regulatory documents and other clinical data reports;
5 Participate in the writing, review, and finalization of regulatory documents (for examples, CSRs), abstracts, and manuscripts for publication;
6 Provide statistical interpretation and explanation of results to team members;
7 Work collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of day to day biostatistics deliverables;
8 Explore the best in class processes and standards for the generation and reporting of data;
9 Support the team of Clinical Biostatistics to meet corporate, regulatory, scientific, and business objectives;
10 Explore appropriate and innovative statistical methods in the design, and analysis of clinical studies;
11 Explore emerging new ways of doing clinical development and new methodologies within focused therapeutic area.
【Responsibilities】:
1 Support other trial statisticians in their responsibilities;
2 Apply appropriate statistical designs, data collection and analysis tools and processes to address the objectives of clinical studies and programs.
【Qualifications】: (Training, Education & Prior Experience)
1. MS (in Statistics or equivalent);
2 Knowledge of / experience with R, SAS, East or any other business or research analytic software;
3 Knowledge of data architecture;
4 Good interpersonal and communication skills;
5 Fluent in both oral and written Englis
职能类别:医药技术研发人员
公司介绍
上海盛迪医药有限公司是江苏恒瑞医药股份有限公司的全资子公司,公司位于上海浦东张江高科技园区,注册成本2.5亿元,占地面积14000平方米。上海盛迪作为恒瑞新药研发的重要组成部分,下设临床医学、中央医学事务、中央市场、临床前开发、新药协调、商务发展、转化医学、对外研发合作等核心职能。
联系方式
- 公司地址:上海浦东新区 (邮编:201210)
- 电话:19551398868