Senior Statistical Programmer

Role Summary

Senior Statistical Programmer for Real-World Data (RWD) / Real-World Evidence (RWE) generation. Lead programming activities to support analyses using large-scale healthcare data sources and collaborate with biostatistics, epidemiology, and medical affairs to design, implement, and deliver analytic datasets, outputs, and visualizations to inform strategic decisions.

Responsibilities

• Develop, validate and maintain analysis-ready datasets, tables, figures and listings for observational and RWE studies from claims, EHRs and registries.
• Conduct exploratory data analyses to support evidence generation and study design refinement.
• Interact with study leads and stakeholders to identify efficient programming solutions and contribute to analytic strategy.
• Standardize and automate data processing workflows, including reusable programming templates and data refreshes.
• Design and develop visualizations and dashboards (e.g., Power BI, Spotfire, R-Shiny) to support decision-making.
• Apply best practices to develop and deliver high-quality reports independently.
• Write, test and validate programs to produce analysis datasets, TLFs and presentation outputs for regulatory submissions and publications.
• Understand and execute department-, product- and study-level macros and utilities; write and validate product- and study-level macros.
• Provide technical programming expertise and guidance on complex tasks and standards.
• Contribute to development and review of Statistical Programming policies and SOPs; interface with outsourcing partners and vendors.
• Other duties as assigned.

Qualifications

• Master’s degree with 2+ years’ RWD programming experience in healthcare analytics using R or SQL; SAS required; 3+ years’ clinical research and development programming using R or SQL, SAS preferred.
• Strong proficiency in SQL and R (SAS a plus) or other data manipulation languages for large-scale healthcare datasets.
• Basic knowledge of statistical analysis methodologies and study design concepts.
• Fundamentals of project planning and management; understanding of drug development process.
• Excellent verbal and written communication skills; strong problem-solving abilities; able to work independently and collaboratively in a fast-paced environment.

Skills

• Expert-level R, SQL or SAS programming for large-scale healthcare data; experience delivering complex analyses.
• Deep knowledge of real-world data sources (claims, EHRs, registries) and observational study design.
• Healthcare coding systems knowledge (ICD, CPT, NDC).
• Experience supporting HEOR, epidemiology or medical affairs teams; Oncology experience; experience with regulatory submissions.
• Experience leading or collaborating with centralized programming teams; familiarity with FDA/EMEA/CFDA processes.

Education

• Master’s degree (required).

Additional Requirements

• Location details not specified; if travel or location-specific requirements exist, they should be listed here.