Statistical Programmers / Sr. Statistical Programmers
方达医药技术(上海)有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2012-08-08
- 工作地点:上海-浦东新区
- 招聘人数:1
- 工作经验:三年以上
- 学历要求:本科
- 语言要求:英语
- 职位类别:临床数据分析员
职位描述
Position Summary:
Frontage is seeking several statistical programmers to join our China Biometric operation in Shanghai or Beijing office. The Statistical Programmer(s) will provide advanced technical expertise as part of the Statistical Programming team to develop and maintain programs to meet internal and external clients' needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks in term of Tables, Listings and Figures (TLFs).
Job Responsibility:
1. Develop statistical programs to support creation and validation of tables, listings and figures for clinical and non-clinical studies
2. Build programming specifications for safety and efficacy analysis database based on the Statistical Analysis Plan and report specifications
3. Create analysis datasets, tables, listings and figures to support writing of Clinical Study Reports and other regulatory filings
4. Document all work with careful attention to traceability and reproducibility
5. Validate analysis datasets and tables, listings and figures created by another team member
6. Represent the programming group in project team meetings and interact with Biostatisticians, Medical Writers, Clinicians, Data Managers and other programmers
7. Review and provide feedback on statistical analysis plans, output specifications and other guideline document
8. Review and provide feedback on CRFs and edit specifications
9. Support the writing of final clinical study reports by providing necessary ad-hoc programming
10 Contribute to the development the technical infrastructure to expedite operations and improve quality control
11. Contribute to the development of CDISC and ADaM data standards
Qualifications:
1. Masters in Statistics, Computer Science and related life science discipline plus minimum 2-3 years of experience in the contract research organization (CRO). Bachelor's degree with minimum 4 years of experience will be considered
2. Proficiency in SAS programming including, but not limited to, Base SAS, SAS/STAT, Macro language
3. Excellent verbal and written communication skills is a must
4. Skilled in identifying issues related to statistical analysis and basic knowledge in statistics
5. Experience with Phase 1 to 3 clinical trials, ISS/ISE and regulatory submission is highly desirable
6. Experience with CDISC SDTM and/or ADaM is highly desirable
7. Ability to work on several projects simultaneously
公司介绍
方达医药始终坚持“中美两国,同一质量体系”准则,获得数据可用于全球申报,目前已为全球400多家客户提供高质量、高标准的新药和仿制药研发服务。作为中国制药企业国际化及高端药物研发合作伙伴,方达医药拥有技术熟练的专业团队,配备了国际最先进的药物研发仪器和设备,并努力为客户创造友好轻松的合作和沟通环境。专注于一体化的专业服务,业务范围包括生物分析、BE临床服务、CMC药品制剂研发、cGMP咨询及国际药品注册等服务项目。
● 我们为员工提供全面的福利待遇,并履行对员工健康和福利的全面承诺。
● 我们为员工提供了与***制药公司合作的机会,让其成为药物开发过程的关键贡献者。
● 我们为员工提供良好的职业发展机会,确保员工在行业内不断积累经验。
● 我们的员工是最有价值的资产,我们拥有明确的员工奖赏计划,肯定员工的奉献精神,奖励员工的辛勤付出。
您也可以发送简历至招聘邮箱:recruitment@frontagelab.com.cn
更多信息请浏览公司网站:**********************
联系方式
- Email:recruitment@frontagelab.com.cn
- 公司地址:地址:spanhomebase