盖博医药信息咨询服务（上海）有限公司诚聘临床试验数据分析师 SAS Programmer

hopeoflight

<br /><br />Responsibilities:- 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.Requirements: - 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.

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