Principal Biostatistician FSP, RWE

Job Requirements

• Collaborate with multi-disciplinary project teams to establish project goals and timelines.
• Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies.
• Serves as subject matter expert for RWE/HEOR/HTA research design, methodologies, data sources, analytic techniques, and reporting.
• Writes statistical analysis plans.
• Provides strategic and tactical support for cross-functional RWE development for regulators, payers, and clinicians.
• Leverages administrative claims, electronic medical records, registries, or other real-world data and recommends optimal analysis.
• Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives.
• Develops high quality study protocols, statistical analysis plans, study reports, and other study documents.
• Identifies innovation opportunities for the use of RWD.
• Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWD.
• Commitment to maintaining the highest standards of data accuracy and integrity by implementing rigorous quality control processes throughout the data handling and analysis phases.
• Demonstrated ability to quickly adapt to new requirements and efficiently handle ad-hoc requests.

Required Knowledge, Skills, and Abilities

• In-depth knowledge of RWE databases, including large administrative claims data, EMR, disease registries, and clinical trial data.
• Demonstrated ability in evaluation and development of RWE from conceptualization through application.
• Familiarity with LOINC codes, reimbursement and lab data interpretation, and ability to implement surrogate variable algorithms (e.g., phenotype definitions, proxies for clinical endpoints)
• Ability to execute statistical analysis plans using advanced programming techniques to perform detailed and complex analyses relevant to real-world evidence.
• Ability to effectively interpret and communicate research results to internal and external audiences.
• Understanding of ICH GCP and E9 as well as general knowledge of industry practices and standard
• Knowledge of global regulatory and HTA requirements for RWE
• Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion.
• SME-level proficiency in SAS programming tailored to handle complex inclusion and exclusion criteria, conduct propensity score matching, and develop outcome metrics.

Required Education and Experience

• Ph.D. in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries.
• Solid hands-on experience as Project statistician with real-world data, including EMR/EHR and claims datasets (e.g., Humedica, Optum, MarketScan, CMS, Komodo, Truveta, TrinetX, etc.)
• Fluency in LOA, mock TFLs, protocol and SAP
• Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD
• Experience with CDISC ADAM datasets.
• Extensive working experience with stakeholders such as medical affairs and health economics

Preferred but not Required Experience

• Understanding of payer landscape, health economic outcomes, and value demonstration frameworks
• Exposure to regulatory submissions, HTA support.
• Expertise in R is also valued.