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Principal Statistical Programmer

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Primary Location: Durham, North Carolina, United States Additonal Locations: Kirkland, Canada,CAN Full time R1329566

Job description

Job Summary

This position is responsible for overseeing and participating in the development and validation of datasets, tables, listings and figures according to statistical plans in support of clinical trials research for IQVIA's FSP department. This function includes providing technical expertise in one or more focus areas; proposing and developing utilities to increase departmental efficiency and/or quality; and mentoring other team members.

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, etc.) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRFs, etc.)
  • 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
  • Ensure accuracy of database and develop database checks for routine situations and with limited supervision develop checks for non-routine situations
  • Manage and maintain programming specifications for SDTM, ADaM, analysis dataset, analysis outputs, and integration of data in support of ISS/ISEs
  • Develop and provide department training for applications and standard tools
  • Responsible for identifying opportunities for productivity improvements and formulating proposal for new SAS utilities/macros and their implementation.
  • Serve as SME advising Biometrics leadership on promoting data quality through various software technologies, programming tools, and techniques, data standards, as well as process improvement in support of clinical data cleaning, review, and monitoring activities
  • Responsible for formulating proposals for new utilities and/or tools as well as presenting information on existing utilities and/or tools
  • Effectively mentor non-clinical programming peers’ functional operations, departmental processes, and data issues
  • Responsible for developing and maintaining good client relationships
  • Guide clients on possible options for deliverables for non-routine requests
  • Train and/or mentor new statistical programmers on statistical programming practices
  • Other duties as assigned

Required Skills

  • 8+ years of experience in SAS programming
  • Bachelor’s degree in Math, Stats, or Computer Science
  • 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
  • Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG
  • High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF
  • Demonstrated teamwork, pride of ownership, and accountability.  Problem solving and innovative skills that demonstrate initiative and motivation
  • Extremely strong communication skills, both oral and written, with all stakeholders

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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