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Edwards Lifesciences

Develops transcatheter heart valves and devices

Senior Biostatistician

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeIrvine, CA, USA

About the Job

Requirements

  • A master's degree or equivalent in Statistics, Biostatistics, or a related quantitative field, with at least 2 years of relevant analytical experience, is required; alternatively, a Ph.D. or equivalent in Statistics, Biostatistics, or a related field with an internship, senior projects, or thesis in Statistics, Biostatistics, or a related field is required.
  • Proficiency in SAS and/or R, including data management, statistical programming, and production of high-quality analytic outputs.
  • A strong foundation in applied statistics and observational research methods, with the ability to select, implement, and explain appropriate analytic methods.
  • Experience designing and analyzing real-world evidence studies using healthcare claims, electronic health records, registries, administrative data, or linked clinical and real-world data.
  • Knowledge of observational research methods, including confounding control, causal inference, missing-data methods, and sensitivity analyses.
  • Experience with longitudinal analysis, generalized linear models, generalized estimating equations (GEE), mixed models, survival and competing-risk methods, propensity score methods, and sample size or power calculations.
  • Experience working with large, complex datasets and creating reproducible, well-documented analytic workflows.
  • Strong written, verbal, and visual communication skills, organization, attention to detail, and ability to manage multiple priorities.

Responsibilities

  • Design and execute real-world evidence, health economics, and outcomes research studies aligned with market access and business needs.
  • Develop statistical analysis plans (SAPs), study specifications, endpoint and cohort definitions, and programming requirements for assigned observational research studies.
  • Apply advanced statistical and epidemiologic methods to claims, electronic health records, registries, clinical trial-linked data, and other real-world data sources to address confounding, selection bias, missing data, and other limitations inherent in observational research.
  • Develop and execute reproducible, well-documented statistical programs for planned, exploratory, and ad hoc analyses, with appropriate quality control.
  • Review study protocols, research plans, and data specifications, and provide statistical input on study design, data feasibility, cohort and endpoint definitions, analytic methods, and interpretation.
  • Identify meaningful patterns and evidence gaps to inform research priorities and strategic decision-making.
  • Interpret complex findings and communicate their implications, assumptions, and limitations clearly to technical and nontechnical audiences.
  • Perform independent validation of statistical programs, analyses, tables, figures, study reports, abstracts, manuscripts, and other scientific deliverables.
  • Author or contribute to statistical sections of study protocols, statistical analysis plans, study reports, abstracts, conference presentations, manuscripts, and responses to scientific review.
  • Partner with cross-functional teams to clarify evidence needs, assess data feasibility, and ensure analyses are scientifically sound and accurately presented.
  • Serve as a statistical resource to colleagues and cross-functional partners, providing guidance on analytical methods and interpretation as appropriate.
  • Stay current with developments in biostatistics, epidemiology, causal inference, real-world evidence, and medical technology through literature review, professional meetings, workshops, and continuing education.

Desired Qualifications

  • A master's degree or Ph.D. in Epidemiology, Data Science, Health Economics, or a related quantitative field.
  • Familiarity with health economic analyses, predictive modeling, machine learning, or simulation methods.
  • Experience with SQL, Python, version control, Tableau, Power BI, or related analytic and visualization tools.
  • Experience contributing to peer-reviewed publications, conference abstracts, posters, or presentations.

About the Company

Edwards Lifesciences

Develops transcatheter heart valves and devices

Edwards Lifesciences focuses on cardiovascular medical technologies, especially transcatheter heart valves. Its products enable repairing or replacing diseased heart valves through minimally invasive procedures rather than open-heart surgery. The company builds on a long history that began with the Starr-Edwards valve and now centers on valve therapies and related diagnostics to treat heart disease. It differentiates itself by specializing in valve technologies and transcatheter approaches, backed by a track record of clinical leadership and global reach. The goal is to improve patient outcomes by providing safer, less invasive valve treatment options for people around the world.

Company size
10,001+
Company stage
IPO
Headquarters
Irvine, CA
Founded
1958

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