Senior Statistical Programmer (FSP, Home-based)

About the role

IQVIA is recruiting a Senior Statistical Programmer under its Functional Service Provider (FSP) arrangement, working remotely from home. The role reviews datasets in submission-ready ADaM format, tables, figures, listings and submission packages, and provides expertise in designing, developing and quality controlling SAS programs that access, extract, transform, review, analyse and submit clinical data. It is dedicated to one of IQVIA's largest clients.

Key responsibilities

• Collaborate with study teams to design data structures and specifications for ad hoc and study deliverables such as ADaM datasets, tables, figures, listings and analysis submission content.
• Ensure the quality and accuracy of clinical data (SDTM, ADaM, tables, figures, listings, define.xml) so that submissions are ready.
• Lead pooled and exploratory analyses, working with the Statistics TA lead, study statisticians and the clinical programming team, including legacy data.
• Lead the in-house specification and delivery of ISS and ISE datasets and their outputs when not provided by the CRO.
• Lead the design and implementation of complex SAS programs for CDISC ADaM analysis and reporting.
• Develop global tools that increase the efficiency and capacity of the Statistical Programming group.
• Plan and execute activities with clinical study teams to meet project timelines with high-quality deliverables.
• Additional tasks: support regulatory agency responses, generate an integrated summary of safety and efficacy, support publications and presentations, and run exploratory analyses to plan and report clinical trials.

Required profile

• BSc in Computer Science, Mathematics, Statistics or a related field with relevant experience.
• At least 5 years of experience in clinical programming and/or statistical programming in a CRO or pharmaceutical environment using SAS.
• Proven experience leading programming for pooled and exploratory analyses across multiple studies and submission activities (or equivalent).
• Ability to work independently and in teams, manage own timelines, and experience in cross-functional, multicultural and international clinical trial teams.

Required skills

• Extensive SAS programming, including SAS macros.
• Good hands-on experience in R.
• Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM).
• Strong programming and problem-solving skills.

What we offer

• Home-based remote work opportunities.
• Work-life balance and a variety of therapeutic areas, indications and study phases.
• Job stability with long-term engagements and career advancement opportunities.