美斯达（上海）医药开发有限公司

发布时间：2008-09-26
工作地点：上海
信息来源：上海交大就业网
职位类型：全职
职位描述
上海张江高科技园区郭守敬路498号浦东软件园21307-21309室

邮政编码: 201203

电话: +86-21-50276030

传真: +86-21-50807377

E-mail: info@

网址: ww***.cn[点击查看]

license: 310115400187883

我们的业务

　　美斯达公司在临床试验领域提供的服务包括: 临床试验方案的设计，数据库的设计和建立，病例报告表的设计，数据管理，统计分析计划(SAP)的撰写，CDISC (Clinical Data Interchange Standards Consortium) SDTM/ADaM和分析数据集的建立，使用SAS进行统计学分析，制作统计表，统计图及数据列表，对新药综合疗效(ISE)及安全性(ISS)报告作统计分析，撰写独立的统计学报告，以及注册申报用的临床试验报告，出席美国或中国的药政机构审评会，回答数据统计问题，支持药品注册申报。

美斯达公司擅长对FDA新药审评委员会和数据安全委员会(DSMB)提供统计分析服务。我们具有丰富的医药及临床试验经验，尤其擅长下述治疗领域：疼痛、癌症、心血管、呼吸系统、中枢神经系统、抗病毒、抗生素、和消化系统等。

我们的目标

　　成为最可信赖的、高质量、高效率-价格比、专业从事临床试验数据管理和生物统计的CRO，具备国际水准，提供全球服务。

我们的客户

　　我们的美国公司已有多年成功经验，我们向医药、生物技术和医疗器械公司，以及美国国立卫生研究院提供临床试验数据管理、生物统计及报告的专业服务

美斯达(上海)医药开发有限公司招聘

Biostatistician

Job Requirements:

Education: M.S., Ph.D., or equivalent experience

Field of Study: Statistics, Biostatistics or related fields

Language: Excellent English skills with CET-6.

Job Description:

Be responsible for the design and analysis of clinical trials. Details are:

Make statistical contributions to the clinical programs including the co-authoring of protocol, calculating sample size, developing randomization schedule, authoring statistical analysis plan, conducting statistical analysis using SAS and/or writing of the statistical results;

Collaborate with data management in the development and implementation of data quality assurance plans;

Apply and justify various statistical methods for analyses. Participate in peer-review of statistical work;

Help maintaining the communication with the sponsor for all biostatistics related activities.

Experience: Two years of working experience, preferable as a biostatistician with CRO or pharmaceutical companies. Must have knowledge in statistical theory including experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, non-parametric methods. Experience in SAS programming is preferred.

Competencies: Ability to learn, team work, quality orientation, effective communication.

SAS Programmer

Education: B.S.. M.S. or higher is preferred.

Field of Study: Statistics,Mathematics, Biostatistics or related fields

Language: Excellent English skills with CET-6.

Job Description:

Write SAS programs to generate analysis datasets and TFL (Tables, Figures and Listings) for final reports. Help data management personnel to write data quality check.

Detailed job descriptions are:

Develop statistical programs using SAS to analyze clinical/non-clinical trial data;

Assess data accuracy and consistency, identify protocol violations, implement statistical analyses, design and develop analysis files and produce TFL;

Participate in the development of case report forms and quality control specifications;

Use and improve company SAS macros.

Experience: Two years of working experience, preferable in SAS programming.

Competencies: Ability to learn, team work, quality orientation, effective communication.