Principal Statistical Programmer RWE

Why DSSS

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 IQVIAs DSSS business unit you are not just another cog in the machine; you become a core part of a dynamic team dedicated to reshaping the future of healthcare.

Responsibilities:

• 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 realworld data and realworld evidence.
• Assist sponsor client with establishing standards/processes for handling realworld data.
• Ensure all programming activities comply with CDISC standards (SDTM and ADaM) and regulatory guidelines (ICH E6 E3 E8 E9.
• In addition to performing all senior statistical programmer duties the Principal Statistical Programmer will also assist all the Sr. Programmers and Programmers in their daytoday activities and act as escalation point for complex programming queries
• Regularly communicates with the sponsor on the progress of programming aspects of the project and proactively anticipates issues and works 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 the SAS Macros and determine macro development priorities
• Utilizing R programming to assess and program EMR data via GitHub repositories set up by client

Education and Experience:

• Minimum 8 years SAS programming experience within Clinical Research Organization or sponsor environment plus 3 years of recent lead experience required
• Bachelors degree in Statistics Computer Science Biology Pharmacy or related.
• Must have good knowledge of CDISC standards (SDTM and ADaM)
• Must have expertise of SAS Base and good knowledge of SAS graph and SAS Macros.
• Moderate R programming ability is required
• Experienced with handling realworld 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.

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

We are committed to providing equal employment opportunities for all including veterans and candidates with disabilities. ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID19 vaccination status. potential base pay range for this role when annualized is $117400.00 $218000.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). 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.