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Principal Biostatistician FSP – Rwe
| Company | IQVIA |
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| Location | Durham, NC, USA |
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| Salary | $131300 – $243900 |
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| Type | Full-Time |
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| Degrees | Master’s, PhD |
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| Experience Level | Senior |
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Requirements
- 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 standards
- Knowledge of global regulatory and HTA requirements for RWE
- PhD in Statistics, Biostatistics, or related field with 5+ years industry experience or MS in Statistics, Biostatistics, or related field with 7+ 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 making LOA, mock TFLs, protocol and SAP
- Experience in cost analysis and healthcare resource utilization (HCRU) evaluation using RWD
- 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.
- Expertise in R is also valued.
- Experience with CDISC ADAM datasets.
- Extensive working experience with stakeholders such as medical affairs and health economics.
Responsibilities
- 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.
Preferred Qualifications
- Understanding of payer landscape, health economic outcomes, and value demonstration frameworks
- Exposure to regulatory submissions, HTA support.
