Principal Biostatistician (RWE Specialist - NA and Europe)
Syneos Health, Inc., Florida, New York, United States
Principal Biostatistician (RWE Specialist - NA and Europe)
Updated:
November 5, 2025
Location:
USA-FL-Remote
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do.
Role Overview This position requires an experienced RWE specialist to analyze in‑house real‑world data for clinical trial design across NA and Europe, ensuring adherence to regulatory and data quality standards and collaborating with cross‑functional teams to support high‑quality decision making.
Job Responsibilities
Must be located in NA or Europe; NA candidates must be open to working EST hours.
Previous lead industry experience within RWE/RWD is required.
Understand and be familiar with licensed RWD databases.
Independently identify, access, and assess in‑house real‑world data sources (EHRs, claims, registries, etc.) relevant to clinical trial populations and endpoints.
Access and summarize non‑patient‑level real‑world data (publications, aggregate claims or EHR analytics, federated learnings, external collaborations, etc.) relevant to clinical trial populations and endpoints.
Critically evaluate data quality, completeness, and suitability for specific trial design questions.
Develop RWD exploration plans.
Clean, process, and harmonize raw RWD for analysis, applying data governance and privacy standards.
Use SAS, R, Python and/or other advanced analytical programming tools to perform statistical analyses and generate insights on patient characteristics, treatment patterns, outcomes, and epidemiology.
Prepare clear, concise evidence summaries and visual reports to inform protocol development (inclusion/exclusion criteria, endpoints, comparator selection, feasibility assessments, etc.).
Collaborate cross‑functionally with clinical, regulatory, biostatistics, and medical teams.
Stay current on RWD methodologies, regulatory guidance, and technological advances in the field.
Ensure all work supports timely, high‑quality decision making for new clinical trial design and execution.
Develop new innovative RWD analytical tools where needed.
Qualifications
Strong experience with licensed RWD databases and in‑house data sources (EHRs, claims, registries).
Proficiency in SAS, R, Python and other analytical tools.
Excellent communication and collaboration skills with clinical, regulatory, biostatistics, and medical teams.
Knowledge of RWD regulatory guidance and data governance best practices.
Benefits
Company car or car allowance.
Medical, Dental, and Vision benefits.
Company match 401(k) plan.
Eligibility to participate in Employee Stock Purchase Plan.
Eligibility to earn commissions/bonuses based on company and individual performance.
Flexible paid time off (PTO) and sick time (subject to local regulations).
Salary Range The base salary range represents the anticipated low and high range for this position and will vary based on candidate qualifications, experience, skills, and competencies.
Equal Opportunity Statement Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at
jobs@syneoshealth.com .
#J-18808-Ljbffr
November 5, 2025
Location:
USA-FL-Remote
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do.
Role Overview This position requires an experienced RWE specialist to analyze in‑house real‑world data for clinical trial design across NA and Europe, ensuring adherence to regulatory and data quality standards and collaborating with cross‑functional teams to support high‑quality decision making.
Job Responsibilities
Must be located in NA or Europe; NA candidates must be open to working EST hours.
Previous lead industry experience within RWE/RWD is required.
Understand and be familiar with licensed RWD databases.
Independently identify, access, and assess in‑house real‑world data sources (EHRs, claims, registries, etc.) relevant to clinical trial populations and endpoints.
Access and summarize non‑patient‑level real‑world data (publications, aggregate claims or EHR analytics, federated learnings, external collaborations, etc.) relevant to clinical trial populations and endpoints.
Critically evaluate data quality, completeness, and suitability for specific trial design questions.
Develop RWD exploration plans.
Clean, process, and harmonize raw RWD for analysis, applying data governance and privacy standards.
Use SAS, R, Python and/or other advanced analytical programming tools to perform statistical analyses and generate insights on patient characteristics, treatment patterns, outcomes, and epidemiology.
Prepare clear, concise evidence summaries and visual reports to inform protocol development (inclusion/exclusion criteria, endpoints, comparator selection, feasibility assessments, etc.).
Collaborate cross‑functionally with clinical, regulatory, biostatistics, and medical teams.
Stay current on RWD methodologies, regulatory guidance, and technological advances in the field.
Ensure all work supports timely, high‑quality decision making for new clinical trial design and execution.
Develop new innovative RWD analytical tools where needed.
Qualifications
Strong experience with licensed RWD databases and in‑house data sources (EHRs, claims, registries).
Proficiency in SAS, R, Python and other analytical tools.
Excellent communication and collaboration skills with clinical, regulatory, biostatistics, and medical teams.
Knowledge of RWD regulatory guidance and data governance best practices.
Benefits
Company car or car allowance.
Medical, Dental, and Vision benefits.
Company match 401(k) plan.
Eligibility to participate in Employee Stock Purchase Plan.
Eligibility to earn commissions/bonuses based on company and individual performance.
Flexible paid time off (PTO) and sick time (subject to local regulations).
Salary Range The base salary range represents the anticipated low and high range for this position and will vary based on candidate qualifications, experience, skills, and competencies.
Equal Opportunity Statement Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at
jobs@syneoshealth.com .
#J-18808-Ljbffr