Senior/ Principal Statistical Programmer

The Senior/ Principal Statistical Programmer will be responsible for delivering high-quality statistical programming solutions across clinical development projects. The role involves designing, developing, validating, and maintaining programming workflows that support regulatory submissions and clinical data analysis.

• Perform end-to-end statistical programming activities for ADaM datasets, Tables, Listings, and Figures (TLFs).
• Support regulatory deliverables, including Integrated Summary of Safety (ISS), Integrated Summary of Effectiveness (ISE), submissions, and regulatory queries.
• Develop, validate, and maintain CDISC-compliant SDTM and ADaM datasets according to industry standards.
• Create and enhance reusable programming utilities, macros, functions, and automation solutions to improve efficiency.
• Develop and apply metadata specifications, programming specifications, and data derivation logic.
• Support analysis using clinical trial data, historical trial data, Real-World Data (RWD), biomarker data, and External Control Arms.
• Build and validate analysis cohorts, including datasets used for advanced clinical and real-world evidence studies.
• Apply statistical programming techniques for complex analyses, including survival analysis and propensity score methodologies.
• Collaborate with clinical, statistical, data management, and regulatory teams to ensure accurate and compliant outputs.

Requirements:

The ideal candidate is an experienced statistical programmer with a strong background in clinical research programming, regulatory submissions, and modern analytical approaches. You should have proven expertise in R and SAS, strong knowledge of CDISC standards, and the ability to independently manage complex programming activities.

• 6–10+ years of experience in statistical programming within the clinical research domain.
• Strong hands-on programming expertise in R, with at least 1–3+ years of practical experience.
• Solid SAS programming experience with exposure to clinical trial programming workflows.
• Experience developing clinical datasets, TLFs, and regulatory submission deliverables.
• Strong understanding and practical experience with CDISC SDTM and ADaM standards.
• Knowledge of SQL and/or Python is an advantage.
• Experience working with Real-World Data (RWD), Real-World Evidence (RWE), biomarker data, and external control datasets is preferred.
• Experience in therapeutic areas such as oncology, respiratory, or immunology is highly desirable.
• Familiarity with EHR and claims-based datasets is a plus.
• Experience with survival analysis and propensity score methods is beneficial.
• Strong attention to detail, analytical thinking, and ability to work independently in a remote environment.
• Excellent communication and collaboration skills when working with multidisciplinary teams.

Benefits:

• Fully remote work opportunity.
• Long-term contract engagement with opportunities to contribute to meaningful clinical research projects.
• Competitive salary package based on experience and expertise.
• Opportunity to work with advanced statistical programming methodologies and healthcare datasets.
• Exposure to global clinical development and regulatory submission processes.
• Flexible work environment supporting experienced professionals.