Principal Statistical Programmer

IQVIA is seeking an experienced and highly skilled Principal Statistical Programmer to join its clinical research and development team. This senior-level role is central to the integrity of clinical data submissions, requiring deep expertise in SAS programming, CDISC standards, and regulatory submission processes. The successful candidate will play a pivotal leadership role in ensuring that all datasets, tables, figures, listings, and submission packages meet the highest standards of accuracy and regulatory compliance.

Operating at the intersection of statistical science and clinical data management, the Principal Statistical Programmer will collaborate cross-functionally with biostatisticians, clinical study teams, and CRO partners. This is a high-impact position suited for a seasoned professional who thrives in complex, multicultural, and deadline-driven environments, and who can independently lead end-to-end programming deliverables across multiple clinical studies simultaneously.

• Collaborate with study teams to design data structures and specifications for ADaM datasets, Tables, Figures, Listings, and Analysis Submission content for both ad hoc and planned deliverables.
• Ensure submission readiness of clinical data — including SDTM, ADaM, define.xml, tables, figures, and listings — in accordance with regulatory authority requirements.
• Lead and oversee pooled and exploratory analyses, working closely with Statistics TA leads, study statisticians, and clinical programming teams managing legacy data.
• Direct the in-house specification and delivery of ISS and ISE datasets and associated outputs when not provided by a CRO.
• Design and implement complex SAS programs for analyzing and reporting clinical trial data in CDISC ADaM format.
• Develop and maintain global programming tools that enhance the efficiency and capacity of the Statistical Programming group.
• Plan and execute project activities in close collaboration with clinical study teams to ensure timely, high-quality deliverables.
• Collaborate with CR&D staff on data analysis requests and support responses to regulatory agencies.
• Generate integrated summaries of safety and efficacy; support publications, presentations, and exploratory analyses for planning and reporting of clinical trials.

• Demonstrate at least 7 years of hands-on clinical and/or statistical programming experience within a CRO or pharmaceutical environment using SAS software.
• Design, develop, and quality-control SAS programs — including SAS Macros — for extracting, transforming, analyzing, and submitting complex clinical data.
• Apply advanced knowledge of CDISC standards (CDASH, SDTM, ADaM) to ensure regulatory-compliant data submissions.
• Use R Programming tools independently, having undergone formal training or accumulated practical hands-on experience.
• Lead programming activities for pooled and exploratory analyses across multiple clinical studies and submission packages simultaneously.
• Manage own timelines and deliver results independently while also contributing effectively within cross-functional, multicultural teams.
• Communicate technical findings clearly to both technical and non-technical stakeholders including statisticians, clinical leads, and regulatory teams.
• Hold a BSc in Computer Science, Mathematics, Statistics, or a closely related quantitative discipline.

IQVIA offers a competitive compensation package commensurate with experience and qualifications. While the specific salary for this role has not been publicly disclosed, Principal Statistical Programmers at this level in the pharmaceutical/CRO industry in Kenya and globally typically earn between KES 350,000 and KES 600,000 per month, or an equivalent gross package aligned to international CRO standards. Benefits are expected to include comprehensive health coverage, performance-based incentives, and access to global learning and development platforms.

Ideal Candidate: You are a seasoned statistical programmer with 7+ years in the CRO or pharmaceutical space, fluent in SAS and well-versed in CDISC standards. You have led complex submission-ready programming deliverables and can navigate regulatory requirements with confidence. You are comfortable working across geographies and cultures, managing competing priorities without losing quality.

Who Should NOT Apply: Candidates with fewer than 5 years of SAS-based clinical programming experience, those without exposure to CDISC standards (SDTM/ADaM), or those primarily from a general IT/software background without clinical trial data experience should not apply at this time. This is not an entry-level or junior programming role.

• Visit the IQVIA careers portal at jobs.iqvia.com and search for the Principal Statistical Programmer position.
• Prepare and submit an updated CV highlighting your SAS programming experience, CDISC expertise, and key clinical submissions you have led.
• Include a brief cover letter outlining your most complex statistical programming project and your specific contribution to it.
• Shortlisted candidates will be contacted for an initial screening interview followed by a technical assessment.