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IQVIA

Accelerate innovation for a healthier world.

Principal Statistical Programmer

Data ScientistData ScientistFull TimeRemoteLeadTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$152K - $227K / year

Seniority

Lead

SASCDISCSDTMADaMNDABLAdefine.xmlSDRGADRGISSISEFDAPMDAclinical trial dataregulatory submissionsstatistical programming

Job Description

Principal Statistical Programmer (Multiple Openings), IQVIA RDS Inc., Durham, NC. May telecommute (work from home) from anywhere in the US and report to Durham, NC company location. Conduct statistical analysis for client reports and publications. Perform advanced statistical programming and biostatistical analyses. Utilize the findings and insights for practical application to further business operations and come across innovative findings and discoveries for solution and product development. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department and provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. Perform all responsibilities associated with the Senior Programmer role. Assist all the Sr. Programmers and Programmers in their day-to-day activities. Act as escalation point for Sr. Programmer and Programmer. Communicate regularly 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. 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. 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 SAS Macros and determine macro development priorities. Perform other responsibilities as defined on ad-hoc basis by senior management. Work, M-F, 40 hours/week. Salary Range: $152,091 - $227,700/year.

Requires a bachelor’s degree in Statistics, Pharmaceutical Sciences or related field or foreign equivalent. Requires five (5) years of statistical programming experience in the life sciences or pharmaceutical industry to include five (5) years with the following: overseeing and guiding programming activities for regulatory submissions with the NDA or BLA; utilizing knowledge of CDISC standards, including SDTM and ADaM, to create and review mapping specifications; preparing and validating submission deliverables such as define.xml, SDRG, and ADRG; performing data analysis and pooling analyses (ISS or ISE); working as a liaison between regulatory agencies (such as FDA or PMDA) and representing programming in cross-functional meetings; utilizing knowledge of clinical trial data and regulatory requirements. Apply: reference id #118694.

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 US $152,091 - $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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