Principal Programmer - RWE

Role Summary :

The RWE Statistical Programmer supports Real-World Evidence (RWE) studies by programming, processing, and analyzing Real-World Data (RWD) from sources such as claims, EHR/EMR, registries, and other observational datasets. The role focuses on building analysis-ready datasets, producing high-quality statistical outputs (TLFs), and ensuring end-to-end traceability and quality control to support publications, regulatory submissions, label expansions and internal evidence generation.

Key Responsibilities :

• Program and maintain RWE study datasets from raw RWD sources (claims, EHR/EMR, registries, etc.).
• Perform data cleaning, standardization, reconciliation, and data quality checks.
• Develop cohort selection logic including inclusion/exclusion criteria, index date, baseline and follow-up periods.
• Derive analysis variables such as treatment exposure episodes, persistence/adherence (PDC/MPR), comorbidity indices (Charlson/Elixhauser), and outcomes.
• Support statistical analyses under the guidance of statisticians/epidemiologists (descriptive analyses, regression models, time-to-event analyses).
• Implement methods such as propensity score matching/weighting/stratification, subgroup and sensitivity analyses (as required).
• Generate Tables, Listings, and Figures (TLFs) for study reports, manuscripts, HTA submissions, and internal evidence packages.
• Create patient attrition flow diagrams, treatment pathways, and utilization trend summaries.
• Perform independent QC of datasets, programs, and outputs; document findings and resolutions.
• Maintain programming documentation including specifications, QC checklists, logs, and version control artifacts.
• Ensure compliance with SOPs, data privacy requirements, and audit readiness standards.
• Collaborate with cross-functional stakeholders (Biostatistics, Epidemiology, HEOR, Medical, Data Management).
• Develop reusable macros/functions to improve efficiency and standardization across studies.