Programmer

Senior Biostatistical ProgrammerThe Senior Biostatistical Programmer is responsible for processing clinical data required for the statistical analysis of Phase I – III clinical trials. Essential functions of the job include conducting statistical programming work of clinical data using SAS Software, ensuring that all programs, outputs, and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs, generating analysis datasets according to CDISC standard and SAP, implementing analysis methods according to SAP, and producing summary tables, graphs, and data listings using SAS; conducting adhoc analyses, validating programs and associated results produced by other programming colleagues, participating in TLF shell preparation and review, and assisting statistician for SAP preparation. The role also involves running CDISC validation programs e.g. OpenCDISC reports to ensure ADaM datasets are CDISC compliant, learning and implementing standard SAS macros for efficient analyses of clinical data supervised by Lead programmers, working independently to program for individual studies with minimum supervision, checking that the validation summary reports are clean of errors and warnings, and showing proper documentation of SAS programs, and reviewing individual study CDISC validation output.Qualifications include a 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, the ability to work well under timeline pressure, and the ability to work on multiple tasks while coordinating others at the same time.