- Provide statistical programming expertise in the production of analyses, tabulations, graphics, and listings from clinical trial data
- Key responsibilities and skills include, but are not limited to, the following: Contribute to the preparation of statistical analysis plans
- Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports
- Contribute to the integrated clinical/statistical report and other similar documents
- Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting
- Perform quality assurance procedures on work performed by others
- Develop, test, validate, document, maintain and execute software and/or systems using the currently endorsed tools or support of production activities
- Assist in the integration of data from remote entry sites, contract research organizations and co-licensing partners to the central database
- BS/MS in statistics, mathematics, or computer science. MS in statistics is preferred
- SAS Institute certification is highly desirable
- Must have at least 3 years of SAS programming experience and at least 1 full year of formal working experience in statistical programming supporting clinical trials
- Must be proficient in data manipulations, reporgraph generations using data steps with varies SAS functions, procedures, macros, and ODS facilities
- Must be experienced with production of data listings, summary tables and graphs for completion of Clinical Study Report and have good understanding of statistical methodologies and clinical trial operations
- NDA experience and/or knowledge of FDA regulations are very helpful
- Excellent communication skill and teamwork spirit are required
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