Senior Statistical Programmer

Job Description

Provides statistical expertise and support with a particular focus on reviewing external data, supporting data transfers, and ensuring the accuracy of statistical deliverables. This role requires a reliable, detail-oriented individual who can work closely with the internal Sponsor team and external partners to ensure analysis and reporting quality, data integrity, traceability, and transparency throughout the study lifecycle. Below are the key responsibilities, core competencies, and education needed for this role.

Location - US ( remote )

Key Responsibilities

• Review and supervise external data transfers to ensure completeness, consistency, and alignment with specifications.
• Review external data and study documentation for accuracy, quality, and readiness for analysis.
• Trace data flow and programming logic from source data to SDTM and from SDTM to Adam to support review and validation.
• Review and provide feedback on SDTM and Adam specifications, tables, listings, figures, statistical analysis plans, protocol amendments, and relevant study documentation.
• Conduct routine study data review to identify inconsistencies, missingness, or other issues that may affect analysis or interpretation.
• Validate statistical outputs, provide independent documentation to ensure results are reproducible and transparent.

Core Competencies

• Collaborate with a cross-functional study team and external vendors to resolve data issues.
• Document review findings clearly and follow up through resolution.
• Working knowledge of CDISC standards, including SDTM and Adam.
• Strong documentation and written communication skills.
• Strong analytical skills and a careful, methodical approach to data review.
• Reliable, detail-oriented, and able to identify issues and provide thoughtful, practical feedback.
• Solid knowledge of statistical analysis methodologies and experimental design.
• Working knowledge of statistical and data processing software e.g. SAS and/or R.

Education

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or a Master’s degree with a minimum of 6 years relevant work experience.