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Principal Statistical Programmer

IQVIA -
Dublin, County Dublin

Apply Now

Job details

Qualifications

Computer Science
XML
SAS
Data structures
R
Bachelor's degree
Quality control

Full job description

Location: Homebased in Ireland, no travel / fully remote

Business Unit: Clinical FSP, sponsor-dedicated

The Principal Statistical Programmer will be responsible for the review of datasets in submission ready standard format (ADaM), tables, figures, listings and submission packages. The Senior Statistical Programmer will provide expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.

Why Join IQVIA?

Collaborate with industry leaders on projects at the forefront of clinical innovation
Gain exposure to a variety of therapeutic areas, indications, and phases
Career development opportunities to grow as we grow, AI‑powered career advancement through our internal talent marketplace, Career Connections
Mentorship opportunities across the organisation via Employee Resource Groups
Flexible working to assist work–life balance and professional success
Join a 2026 Fortune® World’s Most Admired Companies™ - nominated for the FIFTH consecutive year

Responsibilities

Collaborates with the study teams to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content
Collaborates with study teams to ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml)
Leads and oversees requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with clinical programming team and their collection of legacy data
Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO
Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format
Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group
Works closely with clinical study teams to plans and executes activities to ensure project timelines are met with high quality deliverables
Collaborates with CR&D staff regarding data analysis requests
Performs additional statistical analyses including but not limited to:

o Support responses to regulatory agencies
o Generate integrated summary of safety and efficacy
o Support publications and presentations
o Support planning and reporting of clinical trials via exploratory analyses of available data

Requirements

BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
At least 7 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software
In depth understanding of clinical programming and/or statistical programming processes and standards
Extensive experience with statistical programming using the SAS software including development and use of SAS Macros. Strong programming and problem-solving skills
Trained / hands on experience of R Programming
Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent)
Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines
Experience working in cross-functional, multicultural and international clinical trial teams

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 committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Apply Now

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