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Principal Statistical Programmer

Roles & Responsibilities

  • Bachelor’s degree in statistics, pharmaceutical sciences, or a related field, or foreign equivalent.
  • Five years of statistical programming experience, including overseeing programming activities for regulatory submissions (NDA/BLA) and ensuring compliance with global health authority requirements.
  • Experience with CDISC standards (SDTM and ADaM), creating and reviewing mapping specifications, and preparing submission deliverables (define.xml, SDRG, ADRG), plus data integration and pooling analyses (ISS/ISE).
  • Four years mentoring and coaching junior programming staff and developing programming standards, SOPs, and best practices, with a track record of implementing efficiency, quality, or automation improvements.

Requirements:

  • Plan and coordinate the development of integrated programming solutions and provide technical leadership to meet internal and external client needs.
  • Regularly communicate with sponsors on programming progress, anticipate issues, drive resolution, and serve as subject matter expert on SAS programming and CDISC standards.
  • Provide internal consulting, including specifications and user needs analysis, contribute to programming specifications, and mentor programming staff; ensure consistency of output across therapeutic areas.
  • Develop and implement programming standards, SOPs, best practices, plan SAS macro development priorities, oversee process improvement initiatives, and act as escalation point for Sr. Programmers and Programmers.

Job description

Principal Statistical Programmer (Multiple Openings), IQVIA RDS Inc. Durham, NC. May telecommute (work from home) from anywhere in the U.S. and report to Durham, NC company location. Plan and coordinate the development of integrated programming solutions, serving the full spectrum of statistical programming needs. Provide technical expertise to develop process methodology for department to meet internal and external clients’ needs. Regularly communicate with the sponsor on the progress of programming aspects of the project, proactively anticipate issues, and work with the sponsor on resolution of the problems. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. Provide input and/or write the programming specifications. Serve as subject matter expert on all aspects of SAS Programming. Understand pharmaceutical industry standards and trends and proactively plan, develop, and implement accordingly. Develop consistent practices of clinical and statistical review of output and mentor programming staff. Check for consistency across therapeutic areas. Identify, plan, and oversee the implementation and success measures of all process improvement initiatives. Maintain expertise in the use of the SAS Macros and determine macro development priorities. Assist all the Sr. Programmers and Programmers in their day-to-day activities. Act as escalation point for Sr. Programmers and Programmers. Work M-F, 40hrs/week. Salary Range: $158,423 - $227,700/year.

Requires at least a bachelor’s degree in statistics, pharmaceutical sciences, or related field or foreign equivalent. Requires five (5) years of statistical programming experience to include five (5) years with the following: overseeing and guiding programming activities for regulatory submissions (including NDA or BLA), ensuring compliance with global health authority requirements; developing and implementing programming standards, SOPs, and best practices; identifying and implementing tools or processes to enhance programming efficiency, quality or automation; serving as a subject matter expert in CDISC standards, including SDTM and ADaM; creating and reviewing mapping specifications; preparing and validating submission deliverables such as define.xml, SDRG, and ADRG; performing data integration and pooling analyses (including ISS or ISE); four (4) years: mentoring and coaching junior programming staff. Apply: reference job #118693.

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.

The potential base pay range for this role is $158,423 - $227,700 annually. 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.

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