Senior Statistical Programmer (FSP)

About the role

The Senior Statistical Programmer will review datasets in submission‑ready ADaM format, tables, figures, listings and submission packages. The role provides expertise in designing, developing and quality‑controlling SAS programs used to access, extract, transform, analyse and submit clinical data for a range of analyses.

Key responsibilities

• Collaborate with study teams to design data structures and specifications for ADaM datasets, tables, figures, listings and analysis submission content.
• Ensure the quality and accuracy of clinical data to meet regulatory submission standards (SDTM, ADaM, define.xml).
• Lead pooled and exploratory analyses, working closely with statistics leads and clinical programming teams.
• Oversee the specification, delivery and output of ISS/ISE datasets when not provided by CROs.
• Design and implement complex SAS programs for CDISC ADaM‑formatted clinical trial data.
• Develop global tools to increase efficiency of the statistical programming group.

Required profile

• BSc in Computer Science, Mathematics, Statistics or a related field.
• Minimum 5 + years of experience in clinical or statistical programming within a CRO/pharmaceutical environment.
• Strong knowledge of CDISC standards (CDASH, SDTM, ADaM) and experience leading programming activities for pooled and exploratory analyses.
• Proven ability to work independently or as part of multicultural, international trial teams.

Required skills

• SAS programming, including macro development.
• Hands‑on R programming.
• Implementation of CDISC standards (CDASH, SDTM, ADaM).
• Experience with statistical programming for clinical data.