The IQVIA Programming Shared Services Team is part of the Data Sciences, Safety, and Medical pillar of IQVIA. We offer comprehensive Data Management solutions, including full-service, stand-alone, and functional outsourcing models, with expertise across all phases of clinical trials. Our key services include EDC Build and Maintenance, Data Review, and Reporting. We have technical proficiency in major EDC tools such as Medidata RAVE, Oracle Inform, Viedoc, Medrio, and technologies like SAS, Spotfire, Cognos, Python, R, and Business Objects, to name a few.

Minimum Requirements:

• Requires a minimum of Bachelor’s degree in Mathematics (or equivalent) / Computer Science.
• 6 or more years working experience in SAS programming in a CRO or bio/ pharmaceutical setting.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Working understanding of pharmaceutical clinical development and ability to provide programming support for NDA and other regulatory submissions.
• Working understanding of statistical concepts and techniques is expected.
• Working understanding of development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required
• Working knowledge of FDA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems is also required.
• Working knowledge of clinical study is required and biomarker data is preferred.

Description:

• Works collaboratively within Biometrics assisting in providing support to Clinical Data Management activities.
• Works collaboratively with Statistical Programmer, Clinical Data Manager, Biostatistician, Global Drug Safety, Regulatory and Project Management staff and vendors to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
• Ensures completeness, correctness and consistency of clinical data and data structure.
• Provides timely support to the study team on all programming matters according to the project plan and programming specification using internal standards and guidelines. 
• Provides input on clinical data validation specifications and data transfer specifications.
• Contributes to the reporting of routine clinical data through regulatory approval, product launch and annual reports.
• Contributes to the monitoring of data quality during study conduct, providing information on issues along with proposed solutions.
• Ensures completeness, correctness and consistency of clinical data and data structure.
• Acts as Study Lead Clinical Programmer
• Reviews and accepts work by supporting Clinical Programmer
• Attend Study Meeting Team to provide inputs as needed.
• Provides guidance to timeline for deliverables.
• Performs extract, map, transform, and load of clinical data.
• Generates edit checks, listings and reports.
• Performs study tasks.

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 $105,800.00 - $176,300.00. 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.