Associate Principal Statistical Programmer

Associate Principal Statistical Programmer, IQVIA RDS Inc. Durham, NC.  Must telecommute from anywhere in the US and report electronically to the Durham, NC office. Develop, execute, and review programs to provide statistical programming support across multiple clinical studies, overseeing the development and delivery of high-quality statistical programming outputs. Develop and validate safety, efficacy, and inferential results tables, data listings and graphs for analyses of study data or publications using SAS standard coding practices. Create SDTM and ADaM programming specifications associated with analysis datasets, tables, figures, listings, and regulatory submission data packages; and provide programming support for additional business needs such as safety reporting, patient data reviews, and risk mitigation. Apply regulatory knowledge to ensure compliance with submission standards (e.g., FDA, PMDA, EMA). Regularly communicate with the sponsor on the progress of programming aspects of the project and proactively anticipate issues and work with the sponsor on resolution of the problems. Serve as subject matter expert on all aspects of SAS programming. Maintain expertise in the use of SAS® Macros and determine macro development priorities.  M-F, 40 hours per week.  Salary Range: $144,734 - $202,500/year.

Requires at least a bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Information Technology, Regulatory Affairs, Biotechnology, Life Sciences, or related field or foreign equivalent. Requires five (5) years of statistical programming experience to include five (5) years utilizing: SAS programming including Base SAS, SAS/STAT and SAS Macro Language; knowledge of the clinical drug development process;  clinical programming standards including current CDISC data standards for SDTM, ADaM and TLF; programming, developing, and validating standard datasets, tables, listings and figures using SAS; data manipulation, reporting and automation; understanding of safety deliverables and efficacy analysis supporting regulatory submissions; Define.xml, Pinnacle 21, DSUR and PSUR safety deliverables. Apply using Ref# 118690.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.