Senior Statistical Programmer (Oncology)

IQVIA•Durham, NC

18h

About The Position

This role involves conducting statistical programming work on clinical data using SAS Software. The Senior Statistical Programmer will ensure all programs, outputs, and documentation adhere to ICH guidelines and company SOPs. Key responsibilities include generating analysis datasets according to CDISC standards and SAP, implementing analysis methods, and producing summary tables, graphs, and data listings. The position also requires validating programs and results, participating in TLF shell preparation and review, assisting with SAP preparation, and running CDISC validation programs to ensure ADaM dataset compliance. The role involves learning and implementing Incyte standard SAS macros under supervision and working independently on individual studies. A critical aspect is ensuring validation summary reports are error-free and properly documented, and reviewing individual study CDISC validation outputs.

Requirements

BA/BS degree in mathematics, statistics, computer science or health related field, or equivalent experience.
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.

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.