Clinical Trial Specialist supporting French - speaking site start - up, TMF management, and regulatory submissions for Emerald Clinical Trials, a global clinical research CRO.
About the role
- Biostatistician designing real-world evidence studies from EMR and claims data for Syneos Health. Applying causal inference, trial emulation, and statistical programming across healthcare projects.
Responsibilities
- Design and execute real-world evidence studies using EMR and claims data
- Conduct data specifications, statistical analysis plans, and protocols with key research objectives
- Develop and apply robust statistical methodologies, including causal inference methods, GLM/GLMM, MMRM, survival analysis, and random forest
- Apply trial emulation frameworks
- Develop external control arms and borrowing strategies
- Perform data analysis using healthcare coding systems such as ICD and NDC
- Conduct sample size estimation and power calculations for observational and hybrid study designs
- Collaborate with HEOR, Market Access, Regulatory, and Clinical Development stakeholders
- Translate complex analytical results into clear, actionable insights through PowerPoint or study reports
- Support methodological innovation in real-world evidence, including machine learning integration where appropriate
Requirements
- M.S. or Ph.D. in Biostatistics, Statistics, Epidemiology, or related field
- ≥5 years of experience in RWA/RWD analytics (industry or equivalent)
- Strong experience with EMR and/or claims data
- Proficiency in healthcare coding systems (e.g., ICD, NDC)
- Programming expertise in at least one of: SAS, R, or Python
- Working knowledge with SQL logic and OMOP data structures
- Solid understanding of causal inference methods
- Solid understanding of observational study design
- Solid understanding of sample size and power considerations
- Ability to independently write cohort definitions in SQL logic
- Ability to debug data issues, including time zero alignment and exposure gaps
- Understanding of concept mapping (ICD ↔ SNOMED ↔ RxNorm)
- Ability to translate statistical estimands into censoring rules and data extraction logic
- RWE CMH experience
- Equivalent experience, skills, and/or education may be considered
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate
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