Senior Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming)

Overview

In this senior role you own the programming for one or two clinical trials, from setup through submission-ready outputs. You’ll shape analysis plans, build and validate SDTM/ADaM datasets, and ensure CRO deliverables meet regulatory standards. You collaborate across stats, data management, medical writing, and regulatory teams, acting as a technical reference and mentor. This position places you at the core of data quality and auditability, delivering impact across submissions and scientific outputs.

Responsibilities

• Lead programming for one or two clinical trials from setup to analysis and submission
• Design/validate SDTM and ADaM datasets, tables, figures, listings (TFLs)
• Review CRO-delivered deliverables for submission readiness
• Lead integrated analyses (e.g., ISS/ISE) when not handled by CRO
• Mentor junior programmers and contribute to internal processes
• Handle ad hoc analyses and regulatory query responses as needed

Key requirements

• Experience in pharmaceutical/biotech/CRO/clinical research programming
• Strong SAS proficiency (Base/Macro/Stat/Graph); familiarity with R or similar is a plus
• Working knowledge of CDISC standards (CDASH, SDTM, ADaM, define.xml)
• Track record of producing/validating submission-ready TFLs and datasets
• Experience supporting regulatory submissions (FDA; PMDA, NMPA, EMA a plus)
• Comfort working with external vendors and CRO-managed data
• BSc in Computer Science, Mathematics, Statistics or related field (equivalent experience considered)

• mentoring and coaching of peers
• cross-functional collaboration
• attention to data quality and regulatory compliance
• SAS Base/Macro/Stat/Graph
• R or other programming language familiarity
• CDISC standards (CDASH, SDTM, ADaM)

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