Senior Biostatistical Programmer

Job Summary (Primary function)
The 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 (Key responsibilities)
• 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.


Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.