Job Information
IQVIA Principal Statistical Programmer in Durham, North Carolina
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 Statistical Programmer at the Senior or Principal level (based on experience). 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 spec writing and dataset programming for SDTM or ADaM, generating tables, listings, figures, 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:
7 years or more in SAS programming for clinical trial data, working within a CRO or Sponsor environment.
3 years or more working as a study lead for statistical programming activities (to be considered for principal level).
Bachelor’s degree in Math, Stats, Computer Science, Biology, Pharmacy 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 $106,200.00 - $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.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
IQVIA
-
- IQVIA Jobs