Sr./Principal, Statistical Programmer

The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress and provides expert technical support to team members. In addition, the Principal Statistical Programmer fluently and routinely briefs management on accomplishments, status, and issues under their own initiatives, as well as being a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer. Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex clinical trial data in Tables, Listings, and Figures, and for electronic submissions of SDTM, ADaM datasets in CDlSC format, with minimal instruction or input from supervisor. Provides technical and project management leadership to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission. Provides leadership to ensure compliance with company SOP'S and FDA/ICH/GCP regulations. Conducts briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMA, et cetera) for projects with more significant consequences and impact. Performs quality control checks of advanced SAS code for datasets and output produced by other Statistical Programmers. Performs review on define.xml and create reviewers guide for ADaM datasets. Review, maintain study documents per standard process. Program, test, and document global utility programs and tools in accordance with standards and validation procedures. Perform other duties as assigned.