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Biostatistical Programmer / Lead Programmer I,II,III, Biostatistics Programming - United States  

Incyte (company)


Posted on : 13 May 2017

Project Description

This position is responsible for processing clinical data required for statistical analysis of Phase I – III clinical trials, and leading project teams. Job Responsibilities: Conduct statistical programming work of clinical data using SAS Version 9 or above Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs. Participate in the review of ‘Statistical Analysis Plan’ and other documents essential to the conduct of statistical programming work for clinical trials; Generate analysis datasets according to CDISC standard and SAP Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS. Conduct adhoc analyses. Validate programs and associated results produced by other programming colleagues. Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timeline and deliverable are met; Develop standard SAS macros for efficient analyses of clinical data supervised by senior programmers Function as lead programmer in individual project teams for oversight of timeline, quality, and delivery. For Levels II and III, participate in TLF shell preparation and review, and assist statistician for SAP preparation Minimum Requirements: BA/BS degree Minimum 1-8 years of programming experience using SAS Base/Stat/Macro/GRAPH in the biopharmaceutical and/or CRO industries; a MS in statistics or computer sciences is preferred for Levels II and III. Data Management experience and knowledge of CDISC standard are highly desirable Good SAS programming skills and attention to detail are essential Demonstrated knowledge of regulatory biostatistics, SOPs, and guidelines. Highly motivated and able to work well independently as well as being a good team player Strong organizational, time management, communication and project coordination skills for Levels II and III. The Level III position will typically be responsible for several studies concurrently, and supervise the day-to-day activities of programmers assigned to the project Must be able to hands-on and work well under timeline pressure 

Locations

Wilmington DE

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