RWE Statistical Programmer

Overview

The RWE Statistical Programmer (US) is responsible for developing high-quality, analysis-ready datasets and statistical outputs using Real-World Data (RWD), with a strong focus on U.S. healthcare databases such as CMS Medicare and Medicaid claims. 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.

Job Description

Key Responsibilities

·        Program and manage real-world evidence (RWE) datasets using U.S. claims, EHR/EMR, registry, and CMS data sources.

·        Work extensively with CMS databases including Medicare, and Medicaid data, Beneficiary Summary Files, and CCW data.

·        Implement retrospective observational study designs such as cohort, case-control, and cross-sectional studies.

·        Develop cohort selection logic including inclusion/exclusion criteria, continuous enrollment, washout periods, index date, baseline, and follow-up windows.

·        Derive drug exposure episodes using Medicare Part D (PDE) data, including adherence (PDC/MPR), persistence, switching, and discontinuation.

·        Program claims-based outcome definitions using ICD-9/10, CPT/HCPCS, DRG, and NDC codes.

·        Create covariates including demographics, comorbidities (Charlson/Elixhauser), CCW chronic condition flags, and healthcare utilization metrics.

·        Support statistical analyses such as descriptive statistics, ANCOVA, regression models, time-to-event analyses, and comparative effectiveness studies.

·        Prepare analysis datasets for propensity score methods including matching, stratification, and inverse probability weighting (IPTW).

·        Generate Tables, Listings, and Figures (TLFs) for study reports, publications, HTA submissions, and payer dossiers.

·        Develop patient attrition flow diagrams, treatment patterns, and real-world utilization summaries.

·        Perform independent QC of datasets, programs, and outputs to ensure accuracy, traceability, and audit readiness.

·        Maintain comprehensive programming documentation including specifications, QC logs, status trackers and version control.

·        Ensure compliance with SOPs, data privacy requirements, and industry-established standards (CDISC, regulatory guidance, etc.).

·        Collaborate closely with Biostatistics, Epidemiology, HEOR, Medical Affairs, Market Access and remote programming teams.

·        Perform Programming Lead/Client Point of Contact responsibilities such as attending meetings, programming coordination, final delivery reviews, timelines and resource monitoring, as required,

Required Qualifications

·        Bachelor’s or Master’s (preferred) degree in Epidemiology, Statistics, Mathematics, Economics, Biological or Data Sciences or related field.

·        Overall, 8+ years of experience in statistical programming with 5 years of hands-on statistical programming experience in RWE or observational studies with CMS Data.

 

Key Skills

·        Strong hands-on experience with U.S. CMS data (Medicare and/or Medicaid claims).

·        Experience with other real-world data sources, such as claims, EHR/EMR, and/or registry data helpful.

·        Good understanding of observational study design and real-world data limitations (bias, confounding, missingness) and their application to regulatory, safety, and scientific objectives.

·        Strong SAS programming skills

·        Experience in R programming (e.g., tidyverse, survival, MatchIt, tableone) is preferred.

·        Hands-on experience with propensity score methods, survival analysis, and advanced regression models.

·        Experience handling large datasets and performing complex derivations and cohort logic.

·        Experience working with databases and cloud platforms (SQL, Snowflake, Databricks, AWS/Azure).

·        Familiarity with CDISC standards (SDTM/ADaM) and/or RWE Custom Data Models (CDMs) such as OMOP, Sentinel, PCORnet or similar.

·        Knowledge of healthcare coding systems such as ICD-9/ICD-10, CPT/HCPCS, NDC, LOINC, SNOMED (as applicable).

·        Exposure to publication-ready output development and Regulatory/HTA submission deliverables.

·        Good communication skills and ability to work in cross-functional teams.

 

 

 

 

 

 

CMS data is basically healthcare records in the US collected by Centres for Medicare & Medicaid Services.
It includes information like hospital visits, doctor appointments, medicines people take, and medical costs.

 RWE (Real-World Evidence) means using this real-life data (not clinical trials) to understand:

·        How patients are actually treated

·        Which treatments work better in the real world

·        How much healthcare costs

 

Skills & Requirements