Principal Statistical Programmer, RWE

This position is Full-Time and home-based anywhere in North America Why DSSS?Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global CRO while operating within a sponsor environment and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies offering you a unique opportunity to work on a team where your role is both challenging and rewarding, while working alongside colleagues who are passionate about influencing the future of medicine and advancing therapies. With IQVIA's DSSS business unit, you are not just another cog in the machine; you become a core part of a dynamic team dedicated to reshaping the future of healthcare.Additional Benefits:Home-based remote work opportunitiesGreat work/life balanceCollaborate on projects and innovations with industry leaders in the Pharma and CRO sectors Cohesive team environment fostering a collaborative approach to study workVariety of therapeutic areas, indications and, study phasesJob stability; long-term engagements and development opportunitiesCareer advancement opportunitiesResponsibilities:Supporting clients HEOR and Medical Affairs teams to develop and validate statistical programs for data analysis and compliance with industry standards. Ensure all programming activities comply with CDISC standards (SDTM and ADaM) and regulatory guidelines (ICH E6, E3, E8, E9).In addition to performing all senior statistical programmer duties, the Principal Statistical Programmer will also assist all the Sr. Programmers and Programmers in their day-to-day activities and act as escalation point for complex programming queriesRegularly communicates with the sponsor on the progress of programming aspects of the project and proactively anticipates issues and works with the sponsor on resolution of the problemsProvide input and/or write the programming specificationsServe as subject matter expert on all aspects of SAS programmingUnderstand pharmaceutical industry standards and trends and proactively plan, develop, and implementDevelop consistent practices of clinical and statistical review of output and mentor programming staffCheck for consistency across therapeutic areasIdentify, plan, and oversee the implementation and success measures of all process improvement initiativesMaintain expertise in the use of the SAS Macros and determine macro development prioritiesUtilizing R programming to assess and program EMR data via GitHub repositories set up by clientEducation and Experience:Minimum 8 years’ SAS programming experience within Clinical Research Organization or sponsor environment supporting RWE teams, plus 3 years of recent lead experience requiredMust have excellent knowledge of CDISC standards (SDTM and ADaM)Must have expertise of SAS Base, and good knowledge of SAS graph and SAS Macros.Strong R programming ability requiredCapable of implementing more advanced statistical procedures as per specifications provided by biostatistician.Thorough understanding of relational database components and theory.Excellent application development skills.Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis, and reporting of analysis results.Good understanding of ICH E6, ICH E3, ICH E8, ICH E9, and clinical research processes..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 We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.The potential base pay range for this role, when annualized, is $106,200.00 - $218,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.SummaryLocation: Durham, North Carolina, United States of AmericaType: Full time