Principal Statistical Programmer, RWE

IQVIA-posted 7 months ago
$117,400 - $218,000/Yr
Full-time • Senior
Durham, NC
Professional, Scientific, and Technical Services
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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 will be a core part of a dynamic team dedicated to reshaping the future of healthcare.

  • Supporting clients HEOR and Medical Affairs teams to develop and validate statistical programs for data analysis and compliance with industry standards.
  • Act at SME level for requests involving real-world data and real-world evidence.
  • Assist sponsor client with establishing standards/processes for handling real-world data.
  • Ensure all programming activities comply with CDISC standards (SDTM and ADaM) and regulatory guidelines (ICH E6, E3, E8, E9).
  • Perform all senior statistical programmer duties and assist all the Sr. Programmers and Programmers in their day-to-day activities.
  • Act as escalation point for complex programming queries.
  • Regularly communicate with the sponsor on the progress of programming aspects of the project and proactively anticipate issues.
  • 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 the SAS® Macros and determine macro development priorities.
  • Utilize R programming to assess and program EMR data via GitHub repositories set up by client.
  • Minimum 8 years' SAS programming experience within Clinical Research Organization or sponsor environment plus 3 years of recent lead experience required.
  • Bachelor's degree in Statistics, Computer Science, Biology, Pharmacy or related.
  • Good knowledge of CDISC standards (SDTM and ADaM).
  • Expertise of SAS® Base, and good knowledge of SAS® graph and SAS® Macros.
  • Moderate R programming ability is required.
  • Experienced with handling real-world data with advanced content knowledge.
  • Capable 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.
  • Potential base pay range for this role is $117,400.00 - $218,000.00.
  • Incentive plans, bonuses, and/or other forms of compensation may be offered.
  • Range of health and welfare benefits.
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