Senior Statistical Programmer - FSP

Role Overview

This position anchors statistical programming for clinical studies, shaping the data structures and analysis outputs that support regulatory submissions. You will work closely with biostatisticians and clinical teams to turn analysis plans into CDISC-compliant datasets, tables, figures, listings, and submission packages. The role matters because rigorous, reproducible programming is essential for demonstrating safety and efficacy to regulators and for enabling timely, high-quality decisions across a program.

Key Responsibilities

• Define and maintain data specifications for study-specific and ad hoc deliverables, including ADaM datasets, tables, figures, listings, and submission-ready analysis content.
• Collaborate with study teams to verify clinical data quality and accuracy against CDISC requirements such as SDTM, ADaM, and define.xml so submissions are inspection-ready.
• Lead pooled and exploratory analyses in partnership with the therapeutic-area statistics lead, study statisticians, and clinical programmers, drawing on legacy data when needed.
• Own the specification and production of ISS and ISE datasets and associated tables, figures, and listings when external vendors are not supplying them.
• Architect and implement advanced SAS programs, including reusable macros, to generate CDISC ADaM outputs for complex clinical trial analyses.
• Build global programming tools and utilities that improve the Statistical Programming group’s efficiency and capacity.
• Coordinate with clinical study teams to plan and execute programming workstreams, keeping timelines and deliverable quality on track.
• Support data analysis requests from clinical research and development partners, regulatory responses, integrated safety and efficacy summaries, publications, and exploratory trial planning and reporting.

Requirements & Qualifications

• Bachelor’s degree in computer science, mathematics, statistics, or a related quantitative field, paired with relevant professional experience.
• Five or more years in clinical programming, statistical programming, or a comparable role within a CRO, pharmaceutical, or clinical research environment.
• Deep familiarity with clinical and statistical programming processes, standards, and end-to-end study delivery.
• Extensive SAS programming experience, including developing and maintaining SAS macros, with strong problem-solving and programming fundamentals.
• Mandatory hands-on R programming experience for this position.
• Advanced knowledge of CDISC standards, specifically CDASH, SDTM, and ADaM.
• Demonstrated leadership of programming activities for pooled and exploratory analyses across multiple studies and submission efforts, or equivalent experience.
• Proven ability to work independently and in a team setting, manage individual timelines, and meet set goals.
• Experience contributing within cross-functional, multicultural, and international clinical trial teams.