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 IQVIA’s 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 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).
- In addition to performing all senior statistical programmer duties, the Principal Statistical Programmer will also assist all the Sr. Programmers and Programmers in their day-to-day 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 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.
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 We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status The potential base pay range for this role, when annualized, is $117,400.00 - $218,000.00. 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. Apply tot his job Apply To this Job