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IQVIA

Principal Statistical Programmer, Early Phase

Job Posted 3 Days Ago Reposted 3 Days Ago
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Durham, NC
106K-218K Annually
Senior level
Durham, NC
106K-218K Annually
Senior level
Lead statistical programming tasks, ensuring project execution, developing ADaM specifications, validating programs, and managing quality control for clinical trials.
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Principal Statistical Programmer

Location: home-based anywhere in the United States or Canada

Why IQVIA

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 DSSS 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!

Job Responsibilities:

  • Provide hands-on Statistical Programming expertise for client's early phase translation medicine group.
  • Responsible for creating ADaM safety datasets such as ADSL, ADLB, ADVS, ADEX, ADPC (concentration), ADPP (parameter), and POPPK (NONMEM) datasets, PK non-compartmental (NCA) tables, figures, and listings (TFLs).
  • Experience with Phase I studies, exposure response analysis, cross over design, and supported pooling of PK parameters required
  • Strong SAS technical skills and in-depth CDISC knowledge
  • Good knowledge regulatory requirements for submissions

Required Experience:

  • Education/Experience:  Bachelor’s Degree in Statistics, Computer Sciences, Bioinformatics, or related field, and 10+ or more years of relevant experience
  • Strong, recent experience working on Phase 1 studies specifically with PKPD data and having created ADPP and ADPC datasets required
  • Hands-on experience creating NONMEM datasets strongly preferred but will consider candidates who have exposure/knowledge of the process and has worked in-depth with PKPD/Phase 1 studies.
  • Project/Study lead experience strongly preferred but not required

.

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

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

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.

Top Skills

Adam
Cdisc
Meddra
SAS
Sas Enterprise Guide
Sas Grid
Sas Macros
Sas Studio
Sas/Base
Sas/Stat
Sdtm
Unix
Whodrug

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