RWE Statistical Programmer

 

Role Summary
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.
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