Principal Statistical Programmer, FSP

Durham, North Carolina, United States of America

IQVIA

Solutions to help life sciences organizations drive healthcare forward and get the right treatments to patients, faster.

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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 CRO while operating within a sponsor environment and utilizing sponsor systems. Being part of DSS means being part of a passionate team dedicated to advancing medicine and reshaping healthcare. Your role will be both challenging and rewarding, making a real impact.

Experience the best of both worlds and become a core part of our dynamic team today!

Additional Benefits:

  • Home-based remote work opportunities
  • Great work/life balance
  • Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors 
  • Cohesive team environment fostering a collaborative approach to study work
  • Variety of therapeutic areas, indications and, study phases
  • Job stability; long-term engagements, and development opportunities
  • Career advancement opportunities

Job Requirements:

  • Independently develop accurate and CDISC compliant SDTM and ADaM specifications.
  • Independently develop/validate programs that generate analysis datasets based on ADaM specifications.
  • Independently develop/validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan (SAP).
  • Good understanding of regulatory requirements. Prepare XPTs, Define.xml, Reviewer’s Guide, and analysis metadata report, executable programs for CRT packages.
  • Run P21 checks and resolve the P21 validation report related error and document details.
  • Perform quality control on final reports. Generate the ad hoc and custom reports as requested.
  • Provide QC and validation reports and document corresponding details.
  • Communicate with programming and statistics leads, data managers, and other team members.
  • Provide project progress updates of programming activities.

Skills Required:

  • Education/Experience:  Minimum bachelor’s degree in Statistics, Computer Sciences, Bioinformatics, or related field PLUS  8+ years of hands-on clinical trials industry experience.
  • Ability to perform in a fast-paced, scratch programming environment

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 $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.
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Tags: Bioinformatics CDISC Pharma Research Statistics XML

Perks/benefits: Career development Health care

Region: North America
Country: United States

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