Real World Biostatistician - Safety Experience (hiring in US and Canada)

Syneos Health Careers$80K — $145K *
US-AnywhereRemote in North Carolina, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • M.S. or Ph.D. in Biostatistics, Statistics, Epidemiology, or related field.
  • ?5 years of experience in RWD/RWE 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.

Responsibilities

  • Design and execute real-world evidence (RWE) studies using EMR and claims data.
  • Develop and apply robust statistical methodologies including causal inference methods.
  • Implement trial emulation frameworks and external control arm strategies.
  • Perform data analysis using healthcare coding systems.
  • Conduct sample size estimation and power calculations for studies.
  • Collaborate with stakeholders in HEOR, Market Access, Regulatory, and Clinical Development.
  • Translate analytical results into actionable insights for decision-making.

Benefits

  • Company car or car allowance.
  • Health benefits including Medical, Dental, and Vision.
  • 401(k) company match.
  • Eligibility to participate in Employee Stock Purchase Plan.
  • Commission/bonus eligibility based on performance.
  • Flexible paid time off (PTO) and sick time.
Full Job Description
Real World Biostatistician - Safety Experience (hiring in US and Canada)

Job Responsibilities

Job Description

Biostatistician - Real-World Evidence (RWE)

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 Safety experience. This role will support evidence generation across multiple therapeutic areas. This role will focus 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; Conducting data specs, SAP and protocol with key research objectives
  • Develop and apply robust statistical methodologies, including:
  • Causal inference methods (e.g., propensity score methods, weighting, matching; GLM or GLMM, MMRM; survival analysis; random forest)
  • Trial emulation frameworks
  • External control arm development and borrowing strategies
  • Perform data analysis using healthcare coding systems (e.g., ICD, NDC)
  • Conduct sample size estimation and power calculations for observational and hybrid study designs
  • Collaborate cross-functionally with stakeholders across:
  • HEOR
  • Market Access
  • Regulatory
  • Clinical Development
  • Translate complex analytical results into clear, actionable insights, e.g. powerpoint or study report for decision-making
  • 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 related field
  • ≥5 years of experience in RWD/RWE 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
  • Observational study design
  • Sample size and power considerations
  • Some examples: Independently write cohort definitions in SQL logic; Debug data issues e.g., time zero alignment, exposure gaps; Understand concept mapping (ICD ↔ SNOMED ↔ RxNorm); Translate statistical estimand → censoring rule and data extraction logic.


Preferred Qualifications
  • Ph.D. strongly preferred
  • Familiarity with:
  • Trial emulation methodologies
  • External control borrowing / hybrid designs
  • Basic machine learning methods applied to RWD
  • Demonstrated ability to work across multiple therapeutic areas (TAs) in a fast-paced environment
  • Strong communication and stakeholder engagement skills


  • Advanced (nice-to-have, not always required)
  • 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
  • Ability to operate with agility across diverse projects and therapeutic areas
  • Clear and effective scientific communication


Open to all US states and Canada. Remote based position.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:
$80,600.00 - $145,000.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Additional Information

Tasks, duties, and responsibilities as 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.

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