Principal Statistical Programmer, FSP

Location: home-based in the U.S. or Canada

Summary: IQVIA has built a sponsor-dedicated team with a Global Pharma company. We are now expanding this team by adding a Principal/Lead level Statistical Programmer. Expect to be dedicated to this sponsor, working within their environment and progressing with their study efforts over the years. Be highly involved in sponsor-side programming activities including SDTM review, ADaM/TLF programming, ISS/ISE and submission deliverables.

Job duties:

• 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) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF).

• Manage and maintain programming specifications for SDTM, ADaM, analysis dataset, analysis outputs, and integration of data in support of ISS/ISE

• 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

• Responsible for identifying opportunities for productivity improvements and formulating proposal for new SAS utilities/macros and their implementation.

• Responsible for developing and maintaining good client relationships.

Our expectations of you:

• 9 years or more in SAS programming for clinical trial data, working within a CRO or Sponsor environment.

• 4 years or more working as a study lead for statistical programming activities.

• Bachelor’s degree in Math, Stats, Computer Science or related.

• Programming experience of SDTM and ADaM datasets, both production and validation - exposure with both safety and efficacy domains.

• Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG.

• Work independently, exercise good judgment in interpreting, modifying, and adapting company standards, project specifications, tasks, and goals.

• Strong 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.

• High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF.

• Demonstrated teamwork, pride of ownership, accountability, problem-solving and innovative skills.

• Reflect company culture through actions, attitude, and work.

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

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 $111,400.00 - $167,100.00. 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.