Statistical Programmer

The Statistical Programmer will lead key programming activities required for clinical trial data preparation analysis and reporting. The role requires expert-level hands-on programming experience strong CDISC knowledge and the ability to collaborate across teams while ensuring quality accuracy and compliance.

Key Responsibilities

• Perform statistical programming activities to support data analysis interpretation and regulatory submissions.
• Develop validate and maintain SDTM and ADaM datasets in accordance with CDISC standards. Generate high-quality Tables Listings and Figures (TFLs) per SAP and study requirements.
• Prepare and maintain programming deliverables including dataset specifications documentation reviewer guides and QC records.
• Mentor and train junior programmers; help elevate programming standards workflows and best practices.
• Collaborate across biostatistics data management clinical operations and project management to ensure seamless execution of deliverables.
• May serve as Programming Lead on assigned studies.

Qualifications :

• Minimum 6 years of experience as a statistical programmer within clinical trials (pharma biotech or CRO).
• Demonstrated proficiency in TFL programming. Strong command of CDISC SDTM and ADaM standards and submission practices.
• Experience preparing regulatory submission documentation and supporting data review.
• High attention to detail structured communication style and strong documentation discipline.
• Bachelors degree in statistics computer science life sciences mathematics or related field.

Technical Skills

• SDTM and ADaM dataset development and validation TFL programming aligned with SAP and regulatory standards
• Define XML and submission documentation including Pinnacle 21 and reviewer guides QC processes including double programming and traceability
• Knowledge of clinical trial data structures for safety and efficacy SAS programming: Advanced proficiency (Base SAS Macros PROC SQL ODS).
• Familiarity with R for statistical computing and visualization (preferred but not required).
• Working knowledge of CDISC tools and associated validation frameworks.
• Experience using Jira Confluence or equivalent project management tools (preferred).
• Familiarity with Git or other version control systems.
• Experience working in a regulated environment (GxP FDA EMA submission settings).
• Comfort working in Windows and/or Linux command-line environments.

Remote Work :

Yes

Employment Type :

Full-time