Lead Biostatistical Programmer (LBP-DE)
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Wilmington, DE 19803
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 software. Ensure that all programs, outputs, and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs. Generate analysis datasets according to CDISC standards and SAP. Implement analysis methods according to SAP, and produce summary tables, graphs, and data listings using SAS. Conduct ad hoc analyses and validate programs and associated results produced by other programming colleagues. Participate in TLF shell preparation and review and assist statistician for SAP preparation. Run CDISC validation programs (e.g. OpenCDISC reports) to ensure ADaM datasets are CDISC compliant. Develop standard SAS macros for efficient analyses of clinical data supervised by Programming Management. Participate in the review of Statistical Analysis Plan and other documents essential to the conduct of statistical programming work for clinical trials. Work with Clinical Research Organizations, as required, and participate in the oversight and management of programming activities to help ensure quality, timeline, and deliverable are met. Work independently to program for individual studies with minimum supervision. Function as a Lead Programmer for a compound or a group of studies. Maintain the overall timeline and programming standards for assigned studies. Review standard macros and datasets used. Discuss need for programming resources for assigned group of studies. Mentor/train junior programmers on Incyte systems and standards as they work on studies within their area. Assist junior programmers in new study set-up to help identify similar studies. Review production area after study programming is complete to make sure datasets, programs, and outputs are properly stored. Check that the validation summary reports are clean of errors and warnings, and show proper documentation of SAS programs. Review individual study CDISC validation output. Act as a Programming Lead for a submission project under supervision of Programming Management.