Senior Biostatistical Programmer

The Senior Biostatistical Programmer is responsible for processing clinical data required for the statistical analysis of Phase I III clinical trials., “ 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 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. “ 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. “ Learn, and implement Incyte standard SAS macros for efficient analyses of clinical data supervised by Lead programmers. “ Work independently to program for individual studies with minimum supervision. “ 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.

Qualifications (Minimal acceptable level of education, work experience, and competency) “ BA/BS degree in mathematics, statistics, computer science or health related field. “ 4 8 years of SAS programming working experience in the pharmaceutical industry. “ Good SAS programming skills and attention to details “ Demonstrated knowledge of regulatory guidelines, including electronic submission standards. “ Strong organizational, time management, communication, and project coordination and leadership skills. “ Must be able to work well under timeline pressure. “ Must be able to work on multiple tasks while coordinating others at the same time.