Offer summary

Qualifications:

Bachelor’s degree in Statistics, Computer Sciences, Bioinformatics, or related field., Minimum 8 years of hands-on statistical programming experience within CRO or Sponsor environment., Strong SAS programming skills in Windows & UNIX environment, with proficiency in SAS/Base, SAS Macros, and SAS/Stat., Good understanding of clinical trial standards such as CDISC, SDTM, and ADaM..

Key responsabilities:

Lead and coordinate programming tasks to ensure efficient project execution and high-quality deliverables.

Independently develop accurate and CDISC compliant ADaM specifications and generate analysis datasets.

Perform quality control on final reports and generate ad-hoc and custom reports as requested.

Communicate with programming and statistics leads, providing project progress updates on programming activities.

Job description

Principal Statistical Programmer

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

Position Summary:

IQVIA is hiring to expand our sponsor-dedicated team, working fully within the environment of a prominent Pharma company. We are seeking experienced Lead Statistical Programmers with analytical mindsets, excellent hands-on programming experience across SDTM, ADaM/TLF, submission, and ISS/ISE related tasks. This role will be mainly responsible for Study Lead duties such as timeline management, resource allocation, quality control, stakeholder relationship/management, conflict resolution, etc. but will be expected to perform study level programming tasks as needed.

Job Responsibilities:

Lead and coordinate programming tasks, ensuring efficient project execution and high-quality deliverables
Independently develop accurate and CDISC compliant 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 adhoc 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.

Required Experience:

Bachelor’s degree in Statistics, Computer Sciences, Bioinformatics, or related field.
Minimum 8 years of hands-on statistical programming experience within CRO or Sponsor environment PLUS 3 years of recent study lead experience (not co-lead) required.
Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Stat. Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio is a plus.
Experience with all clinical phases I, II, III, and IV clinical trials
Good understanding of standards specific to clinical trials such as CDISC, SDTM, ADaM, MedDRA, WHODRUG
Strong problem-solving skills
Good organizational and time management skills.
Excellent communication and interpersonal skills and capability of communicating technical concepts
Excellent organizational skills with demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.
Experience in submission to regulatory authorities

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.

Required profile