热招_SAS Programmer, Biostatistician

shiyiming

[b:1csdnqcd]1. 临床试验数据分析师 SAS Programmer [/b:1csdnqcd]

[b:1csdnqcd]Responsibilities:[/b:1csdnqcd]
- Performs all SAS programming tasks for a given clinical study or studies involving investigational or non-investigational drugs, biologics and devices.
- Acts as the primary point of contact for all SAS programming activities for a given clinical study or studies.
- Builds standard tabulation datasets according to certain industry standard or the format requested by client or develops SAS programs to produce data listings and Case Report Form Tabulations as by domain or by subject displays
- Builds analysis datasets according to certain industry standard or the format requested by client based on the statistical analysis plan
- Develops SAS programs to implement statistical analyses as specified in the statistical analysis plans and table shells
- Develops SAS programs for other departments' need such as Clinical Data Management, Medical Writing, Quality Assurance and Safety Department
- Performs validation of and quality assurance aspects of all SAS programming activities
- Represents SAS Programming at project team meetings and provides updates to project team on status of tasks
- Communicates with Project Biostatistician, Data Manager, Medical Writer, Project Manager and Project Coordinator regarding project issues
- Ensures adherence to all timelines associated with SAS programming
- Ensures integrity of all systems by preserving security and following change control procedures
- Ensures adherence to guidelines, methodology and SOPs for software development in accordance with FDA, ICH, GCP and SDLC methodology
- Other relevant duties assigned for which the incumbent is qualified.


[b:1csdnqcd]Requirements: [/b:1csdnqcd]
- Bachelor's degree in a scientific or technical area, advanced scientific degree desired.
- Biostatistics or statistics, medical or healthcare related education preferred.
- Minimum 2 years SAS programming experience in clinical research line.
- Good skills in the management and resolution of SAS programming issues.
- Demonstrated team-building skills and ability to work successfully in a team environment.
- Knowledgeable in all aspects of the Federal (FDA) regulations and requirements governing the conduct of drug, biologic and device studies including, but not limited to, GCP and ICH requirements
- Good command of English language and communication skills.


[b:1csdnqcd]2. 生物统计师Biostatistician [/b:1csdnqcd]

[b:1csdnqcd]Responsibilities: [/b:1csdnqcd]
- Performs biometrics and SAS programming activities for all clinical trials involving drugs, biologics and devices, and oversees the activities of programming;
- Develops statistical section in clinical trial protocol;
- Performs sample size calculations to determine the number of patients to include in a clinical trial;
- Develops Statistical Analysis Plan with input from project team and sponsor per SOPs and WPDs;
- Performs SAS programming to generate tables, listings, figures, and statistical analyses;
- Supervises/coordinates activities of relevant consultants and contractors;
- Oversees validation and quality assurance aspects of control over SAS program content, documentation and archiving of programs;
- Ensures adherence to timelines for the biostatistical and SAS programming aspects of projects;
- Other relevant duties assigned for which the incumbent is qualified.

[b:1csdnqcd]Requirements: [/b:1csdnqcd]
- Bachelors degree in biostatistics or related subjects, advanced degree (M.S. or Ph.D) desired
- Minimum 2 years of pharmaceutical statistics and/or statistical programming experience applied to drug or medical device development
- Strong team-building skills and ability to work successfully in a team environment requiring matrix management skills
- Knowledgeable in all aspects of the FDA regulations and requirements governing the conduct of drug and device studies including, but not limited to, GCP and ICH requirements
- Good command of English language and communication skills.  

[b:1csdnqcd]Corporate Information:[/b:1csdnqcd]
Global Medical Consulting Services (Shanghai) Co. Ltd. ([b:1csdnqcd]GMCS[/b:1csdnqcd]) is an international clinical research company (CRO) headquartered in Rockville Maryland,USA. GMCS is located in Shanghai, China and has been in operation since 1998 (formerly Medifacts International). We provide unsurpassed clinical trial management, pharmacovigilance, data management and biostatistical support for clinical development studies to the pharmaceutical, biotech and medical device communities worldwide. GMCS has been audited by a number of international pharmaceutical companies, and was audited by the Chinese SFDA as early as in 2001 with commendation on the quality of operation.
盖博医药信息咨询服务（上海）有限公司（GMCS）是一家国际性临床研究公司（CRO），总部位于美国马里兰州罗克维尔市，公司坐落于上海南京东路黄浦商业圈。自1998年运营以来（前身为美国美迪范国际公司），我们一直为全球的药厂、生物科技企业和医疗器械研发公司提供世界一流的临床试验及管理服务，包括临床管理、药物安全性管理、数据管理及生物统计支持等。盖博医药曾多次接受并通过了诸多国际大药厂的审核，并有幸成为首批通过中国国家食品药品监督管理局核查并获得高品质赞誉的临床研究合同委托公司。

地址：上海黄浦区南京东路299号宏伊国际广场1201
邮政编码：200001
联系人：任小姐
E-mail: <!-- e --><a href="mailto:shanghaihr@grs-cro.com">shanghaihr@grs-cro.com</a><!-- e -->