The Senior Statistical Programmer will oversee the verification of datasets formatted according to submission standards (Adam), as well as tables, figures, listings, and submission packages. This role encompasses specialized guidance in the design, execution, and quality assurance of SAS programs utilized to access, extract, transform, review, analyze, and submit clinical data for all required analyzes.
Why Join IQVIA?
Partner with pioneering figures in the healthcare sector to spearhead groundbreaking clinical initiatives.
Experience opportunities to explore diverse therapeutic domains, indications, and developmental stages.
We provide robust career development opportunities designed to align with our organizational growth, featuring AI-driven career advancement facilitated by our internal talent marketplace, Career Connections.
Professional development through mentorship programs facilitated by Employee Resource Groups is available throughout the organization.
Flexible arrangements are available to support optimal work-life integration and facilitate professional development.
Join an organization recognized as one of the 2026 Fortune World’s Most Admired Companies, distinguished by its fifth consecutive year of nomination.
Responsibilities
Works closely with study teams to develop data structures and detailed specifications for both ad hoc and study deliverables, including Adam datasets, tables, figures, listings, and analysis submission content.
Works collaboratively with study teams to guarantee the precision and integrity of clinical data, ensuring its submission readiness in accordance with regulatory standards such as SDTM, Adam, tables, figures, listings, and define.xml.
Experienced professionals will direct and coordinate all aspects of requested pooled and exploratory analyses, collaborating closely with the Statistics TA lead and/or study statisticians, as well as the clinical programming team and their repository of legacy data.
Experienced professionals in this role are responsible for directing and managing the internal development and execution of ISS and IS datasets, as well as related deliverables such as tables, figures, and listings, particularly in instances where these are not supplied by the Contract Research Organization (CRO).
Oversees and directs the development and execution of sophisticated SAS programs intended for analyzing and reporting intricate clinical trial data structured in DISC Adam format.
Drives the strategic design and implementation of worldwide systems aimed at enhancing the productivity and scalability of the Statistical Programming team.
Collaborates extensively with clinical study teams to organize and implement activities, ensuring project timelines are consistently met while delivering high-quality results.
Partners with CR&D personnel to fulfill data analysis requests, ensuring alignment with project objectives and timely delivery of findings.
Conducts supplementary statistical evaluations encompassing, but not limited to, the following methodologies:
Respond to inquiries from regulatory agencies promptly and accurately to ensure compliance with applicable laws and regulations.
Compile comprehensive safety and efficacy summaries by analyzing and synthesizing relevant data to provide clear, concise overviews of clinical and non-clinical findings. Ensure all critical information regarding product safety profiles, adverse event reports, and efficacy outcomes is accurately documented and presented in a structured format. Collaborate with cross-functional teams, including clinical research, regulatory affairs, and medical writing, to validate data integrity and ensure alignment with regulatory standards and guidelines. Prepare detailed reports suitable for submission to health authorities, internal stakeholders, and external partners, maintaining meticulous attention to detail and adherence to established timelines.
Facilitate the preparation and dissemination of publications and presentations to ensure timely and accurate delivery.
Facilitate the development of clinical trial plans and enhance reporting mechanisms by conducting exploratory data analyses to extract meaningful insights from existing datasets.
Requirements
A Bachelor of Science degree in Computer Science, Mathematics, Statistics, or a closely related field, supplemented by applicable professional experience, is required.
With a minimum of five years of hands-on experience in either clinical or statistical programming, preferably within a CRO or pharmaceutical setting, and proficiency in SAS Software, the ideal candidate will bring a strong technical background to the role.
We possess a thorough comprehension of clinical programming and/or statistical programming processes and standards.
Professionals with significant expertise in statistical programming through SAS are sought for this position, emphasizing the development and implementation of SAS Macros. The ideal candidate will possess advanced programming capabilities and a robust aptitude for problem-solving.
Proficient in R Programming, having received comprehensive training and possessing practical, hands-on experience in its application.
Proficiency in DISC standards, including CASH, SDTM, and Adam, is imperative for this role. A deep understanding of these industry-standard frameworks is essential to ensure compliance with data collection, standardization, and analysis requirements in clinical research.
Accomplished professionals should possess a strong track record in directing programming initiatives for pooled and exploratory analyses spanning diverse clinical studies, as well as submission-related tasks, or equivalent experience.
Demonstrates strong capability to operate autonomously or collaboratively while consistently achieving established objectives through effective time management.
Seasoned professionals with a track record in diverse, multicultural, and international clinical trial teams across various functions will find this opportunity compelling. The ideal candidate brings prior experience collaborating effectively within such environments, demonstrating adaptability and strong interpersonal skills to navigate global research initiatives seamlessly.
Qualifications
BA/BSc/HND
Experience Required
5 years
