Role Overview

We are seeking a biostatistician with strong experience in real‑world data (RWD) with observational study design and safety study experience, in addition to RWE CMH experience. This role will support evidence generation across multiple therapeutic areas. The focus is on the design, analysis, and interpretation of observational studies using EMR and claims data to inform clinical development, HEOR, regulatory strategy, and market access.

Key Responsibilities

- Design and execute real‑world evidence (RWE) studies using EMR and claims data; prepare data specifications, SAP, and protocol with key research objectives.
- Develop and apply robust statistical methodologies, including causal inference methods (propensity score methods, weighting, matching, GLM or GLMM, MMRM, survival analysis, random forest).
- Implement trial emulation frameworks and external control arm development 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 cross‑functionally with HEOR, market access, regulatory, and clinical development stakeholders.
- Translate complex analytical results into clear, actionable insights for presentations or study reports.
- Support methodological innovation in RWE, including integration of machine learning approaches where appropriate.

Required Qualifications

- M.S. or Ph.D. in Biostatistics, Statistics, Epidemiology, or a related field.




- At least 5 years of experience in RWD/RWE analytics (industry or equivalent).
- Strong experience with EMR and/or claims data.
- Proficiency in healthcare coding systems such as ICD and NDC.
- Programming expertise in at least one of: SAS, R, or Python.
- Working knowledge of SQL logic and OMOP data structures.
- Solid understanding of causal inference methods, observational study design, and sample size and power considerations.
- Demonstrated ability to independently write cohort definitions in SQL, debug data issues such as time‑zero alignment and exposure gaps, and understand concept mapping among ICD, SNOMED, and RxNorm.
- Experience with RWE CMH.

Preferred Qualifications

- Ph.D. strongly preferred.
- Experience in one or more therapeutic areas: diabetes, cardiovascular disease, metabolic disorders.
- Familiarity with trial emulation methodologies, external control borrowing/hybrid designs, and basic machine learning methods applied to RWD.
- Demonstrated ability to work across multiple therapeutic areas in a fast‑paced environment.
- Strong communication and stakeholder engagement skills.
- Advanced skills (nice to have): build reusable cohort pipelines,



optimize queries for large‑scale databases, work across multiple CDMs (OMOP, Sentinel, PCORnet).

Core Competencies

- Analytical rigor and methodological depth.
- Cross‑functional collaboration.
- Agility across diverse projects and therapeutic areas.
- Explicit and effective scientific communication.

Additional Information

Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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📌 Real World Biostatistician - RWE CMH experience (hiring in Canada and US) (Toronto)
🏢 Syneos Health
📍 Toronto