Lead Programmer I, II, III, Biostatistical Programming - United States
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This position is responsible for processing clinical data required for statistical analysis of Phase I – III clinical trials, and leading project teams.
- 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
- 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