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Principal Stat Programmer

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Primary Location: Durham, North Carolina, United States Additonal Locations: New York, NY,USA Full time R1273272

Job description

Principal Statistical Programmer – Strategic Partnerships Group

Direct-hire employee, work-from-home

Primary job responsibilities

· Translate study protocol and Statistical Analysis Plan into algorithms and specifications to achieve analysis and CDISC standards

· Create and/or validate all safety and efficacy study output requirements (e.g. SDTM, ADaM, TLFs) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF)

· Manage and maintain programming specifications for SDTM, ADaM, analysis dataset, analysis outputs, and integration of data in support of ISS/ISE

· Communicate an understanding of statistical programming concepts, basic clinical principles and act in accordance with those principles

· Review for consistency across studies within a project; assist with developing project conventions and verifying that conventions are followed

· Provide accurate and timely responses to routine requests from clients and with limited supervision responses to non-routine requests from clients

· Responsible for identifying opportunities for productivity improvements and formulating proposal for new SAS utilities/macros and their implementation.

· Responsible for developing and maintaining good client relationships

Required skills

· Approximately 8 years or more in SAS programming for clinical trial data

· Bachelor’s degree in Math, Stats, Computer Science or related

· Previous experience acting as a lead of programming activities and timelines

· Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG

· Effectively understand, complete trainings, and implement all SOPs, Guidelines, and Work Instructions

· Work independently, exercise good judgment in interpreting, modifying, and adapting company standards, project specifications, tasks, and goals

· Knowledge of pharmaceutical clinical development (i.e. understanding of safety deliverables and efficacy analysis supporting regulatory submissions)

· Knowledge of base SAS, proc report, exposure to macros, current CDISC data structures, and standardization methodology; demonstrated ability to debug SAS programs

· High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF

· Demonstrated teamwork, pride of ownership, accountability, problem-solving and innovative skills

· Reflect company culture through actions, attitude, and work

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at

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.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at to arrange for such an accommodation.

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