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.