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

Summary:

IQVIA has formed a sponsor-dedicated team offering long-term dedication to a Rare Disease Biopharma company. We are seeking to hire a Senior Clinical Programmer, to work fully on sponsor-side activities. This individual will support the Data Management and Biostatistics departments for the sponsor, involvement with the EDC data build process. Create test data in Rave EDC system. Also, there is a job requirement for SDTM programming skills.

Responsibilities:

• Collaborates with peers, data management and statistics to ensure the quality and accuracy of EDC build process.

• The development of programming scripts for data retrieval, transformation and representation as well as their validation.

• Handles implementation and maintenance of internal data quality control programs, acceptance criteria for data from external sources and performs the related programming.

• Work within the data management functional area to handle programming of SDTM datasets.

• Leads the set-up and maintenance of a suite of reports that function as a sample report library for study teams to choose from in order to help them efficiently lead their projects.

• Leads the implementation and organization of automated regular reports on study platforms and oversees correct processing of automated reports.

• Collaborates with the clinical study team in developing ongoing data quality standards and clinical data acceptance rules for clinical data in the eCRF and related external data sources collecting data from clinical studies.

Qualifications:

• Degree (BSc/MSc) in Computer Science, Mathematics, Statistics, or related area with relevant experience. Other degrees and certifications considered if commensurate with related data management and clinical programming experience.

• 7+ years of experience in the areas of clinical data management and/or clinical programming (working within a CRO or Pharmaceutical setting).

• Working experience with Rave EDC is required.

• Understanding of SDTM specifications and programming of SDTM datasets.

• Knowledge in CDISC standards (CDASH, SDTM) is required.

• Previous working experience in programming SDTM datasets.

• Understanding of data management and/or clinical programming processes and standards.

• Knowledge in statistical programming using the SAS software.

• Ability to work in cross-functional, multicultural and international clinical trial teams.

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 - $177,000.00. 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.