Principal Statistical Programmer FSP - RWD/EPI

Accountabilities

• Support epidemiology teams by preparing real-world data, advising on analytical strategies, and contributing to epidemiological research activities.

• Assist in developing study protocols and statistical analysis plans using large real-world data sources, including healthcare claims and electronic health records (EHR).

• Coordinate with data vendors to obtain relevant data extracts in accordance with approved study protocols.

• Build and maintain analytical databases from source data extracts to support statistical analyses.

• Program and conduct statistical analyses under the direction of epidemiologists and statisticians, including data coding, algorithm development, dataset linkage, and application of statistical methods.

• Perform analyses according to study protocols and analysis plans, using appropriate statistical programming tools and techniques.

• Generate tables, figures, visualizations, and reports to communicate observational research findings to investigators, clients, and internal stakeholders.

• Support the standardization, visualization, and reporting of observational data through innovative programming approaches.

• Contribute to Medical Affairs observational studies, Global Patient Safety and Risk Management analyses, and Clinical Development activities, including background-rate assessments and patient population or protocol feasibility evaluations.

• Assist with study reports and other research deliverables, and present findings internally and to clients.

• Manage relationships with internal and external stakeholders, prioritize competing project requirements, and ensure timely delivery of high-quality work.

• Troubleshoot technical challenges and provide reliable programming and analytical support.

• Potentially take on supervisory responsibilities as the role and team needs evolve.

Requirements:

• Master’s degree or PhD in Epidemiology, Biostatistics, Statistics, Bioinformatics, Economics, or a related quantitative discipline.

• At least 5 years of experience conducting real-world evidence analytics within the pharmaceutical industry, a contract research organization (CRO), or an academic institution.

• Intermediate-to-expert proficiency in SQL is essential.

• Strong programming proficiency in SAS or R.

• Extensive experience analyzing real-world data sources, particularly healthcare claims and electronic health records.

• Familiarity with major real-world data platforms and sources such as Optum Clinformatics Datamart®, Market Clarity, Truveta, and UK Biobank.

• Experience working with clinical trial or registry data is an advantage.

• Strong understanding of relational databases, healthcare claims structures, and ancillary file layouts.

• Applied statistical expertise, including regression methods such as ordinary least squares (OLS), longitudinal, logistic, Cox, generalized linear models (GLM), and generalized estimating equations (GEE).

• Experience with survival analysis techniques, including Kaplan–Meier estimates, cumulative incidence, and accelerated failure time models.

• Knowledge of propensity weighting and other methods used in observational research.

• Excellent project management and organizational skills, with the ability to prioritize multiple assignments and meet deadlines.

• Confidence working with internal and external stakeholders, including data vendors, investigators, and clients.

• Strong written and verbal communication skills, with the ability to summarize complex analytical findings and present key evidence clearly.

Benefits:

• Full-time, remote work arrangement.

• Opportunity to contribute to impactful real-world evidence and epidemiology research.

• Collaboration with multidisciplinary experts and stakeholders across research and development.

• Exposure to complex healthcare datasets, advanced statistical methods, and diverse research projects.