Senior Statistical Programmer - FSP

About the role

The Senior Statistical Programmer at IQVIA in Nairobi reviews datasets in submission-ready standard format (ADaM), tables, figures, listings and submission packages. The role provides expertise in designing, developing and quality controlling SAS programs that access, extract, transform, review, analyse and submit clinical data for all requested analyses.

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 required by authorities (SDTM, ADaM, tables, figures, listings, define.xml).
• 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.
• Work with clinical study teams to plan and execute activities that meet project timelines with high-quality deliverables.
• Additional tasks: collaborate with CR&D staff on data analysis requests, support regulatory agency responses, generate integrated summaries of safety and efficacy, support publications and presentations, and run exploratory analyses for trial planning and reporting.

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.
• In-depth understanding of clinical programming and statistical programming processes and standards.
• Proven experience leading programming for pooled and exploratory analyses across multiple studies and submissions (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 programming (mandatory).
• Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM).