Principal Biostatistician (RWE, HEOR) - North America, Europe
Syneos Health, Inc., New York, New York, us, 10261
Updated:
October 23, 2025
Location:
USA-NY-Remote
Job ID: 25102670
Syneos Health Overview 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.
Why Syneos Health
We are passionate about developing our people through career development, supportive line management, technical training, peer recognition and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our culture unites us globally and we are dedicated to taking care of our people.
We continuously build the company we all want to work for and our customers want to work with by bringing together diverse thoughts, backgrounds, cultures, and perspectives, creating a place where everyone feels they belong.
Job Responsibilities
Experience with a variety of RWD including eHR, registry studies, pharmacy data, and CT experience.
Experience with RW safety studies; healthcare claims knowledge is critical.
Required skills include propensity score matching, estimands, logistic regression, survival analysis, incident rate understanding, etc.
Knowledge of safety assessments including disproportionality analyses, statistical surveillance methods, safety risk modeling, data mining, AI/ML, signal detection and other safety assessment skills.
General Experience Serves as a statistical department resource, mentors biostatisticians, oversees training plans, and provides training to new hires. Prepares SAPs, develops mock‑up displays, collaborates with sponsors, and manages statistical aspects of the protocol, randomization schedule, and clinical study reports. Reviews SAS annotated CRFs, database design, and other study documentation to ensure protocol criteria are met. Creates or reviews programming specifications for datasets, tables, listings, and figures. Directs activities of biostatistics personnel and provides independent review of work. Implements company objectives and creates alternative solutions for business and operational challenges. Represents biostatistics on project teams, interfaces with other departments, and participates in verification and quality control of deliverables. Manages scheduling and time constraints across multiple projects, communicates with biostatistics management, and escalates issues. Provides statistical programming support and may participate in DSMBs or DMCs. Leads integrated analyses, attends regulatory agency meetings, and supports statistical analysis results for clinical trials on behalf of the sponsor. Follows SOPs, WIs, and regulatory guidelines including ICH. Maintains project documentation, ensures inspection readiness, and supports business development activities. Performs additional duties as assigned. Minimal travel may be required.
Qualifications
Graduate degree in biostatistics or related discipline.
Extensive experience in clinical trials or equivalent education and experience, demonstrating the ability to lead multiple projects.
Proficiency in programming.
Ability to apply statistical design, analysis, regulatory guidelines, and programming techniques in clinical research; effective communication of statistical concepts.
Experience with regulatory submissions preferred.
Excellent written and verbal communication skills.
English language proficiency.
Benefits & Compensation Salary Range: $95,000.00 – $175,700.00
Company car or car allowance.
Health benefits including Medical, Dental, and Vision.
Company match 401(k).
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.
Contact Information Phone: 919 876 9300 Fax: 919 876 9360 Toll-Free: 866 462 7373
Equal Opportunity Employment 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, veteran status, disability or any other legally protected status. If you require reasonable accommodation to complete any part of the application process, please contact jobs@syneoshealth.com.
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October 23, 2025
Location:
USA-NY-Remote
Job ID: 25102670
Syneos Health Overview 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.
Why Syneos Health
We are passionate about developing our people through career development, supportive line management, technical training, peer recognition and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our culture unites us globally and we are dedicated to taking care of our people.
We continuously build the company we all want to work for and our customers want to work with by bringing together diverse thoughts, backgrounds, cultures, and perspectives, creating a place where everyone feels they belong.
Job Responsibilities
Experience with a variety of RWD including eHR, registry studies, pharmacy data, and CT experience.
Experience with RW safety studies; healthcare claims knowledge is critical.
Required skills include propensity score matching, estimands, logistic regression, survival analysis, incident rate understanding, etc.
Knowledge of safety assessments including disproportionality analyses, statistical surveillance methods, safety risk modeling, data mining, AI/ML, signal detection and other safety assessment skills.
General Experience Serves as a statistical department resource, mentors biostatisticians, oversees training plans, and provides training to new hires. Prepares SAPs, develops mock‑up displays, collaborates with sponsors, and manages statistical aspects of the protocol, randomization schedule, and clinical study reports. Reviews SAS annotated CRFs, database design, and other study documentation to ensure protocol criteria are met. Creates or reviews programming specifications for datasets, tables, listings, and figures. Directs activities of biostatistics personnel and provides independent review of work. Implements company objectives and creates alternative solutions for business and operational challenges. Represents biostatistics on project teams, interfaces with other departments, and participates in verification and quality control of deliverables. Manages scheduling and time constraints across multiple projects, communicates with biostatistics management, and escalates issues. Provides statistical programming support and may participate in DSMBs or DMCs. Leads integrated analyses, attends regulatory agency meetings, and supports statistical analysis results for clinical trials on behalf of the sponsor. Follows SOPs, WIs, and regulatory guidelines including ICH. Maintains project documentation, ensures inspection readiness, and supports business development activities. Performs additional duties as assigned. Minimal travel may be required.
Qualifications
Graduate degree in biostatistics or related discipline.
Extensive experience in clinical trials or equivalent education and experience, demonstrating the ability to lead multiple projects.
Proficiency in programming.
Ability to apply statistical design, analysis, regulatory guidelines, and programming techniques in clinical research; effective communication of statistical concepts.
Experience with regulatory submissions preferred.
Excellent written and verbal communication skills.
English language proficiency.
Benefits & Compensation Salary Range: $95,000.00 – $175,700.00
Company car or car allowance.
Health benefits including Medical, Dental, and Vision.
Company match 401(k).
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.
Contact Information Phone: 919 876 9300 Fax: 919 876 9360 Toll-Free: 866 462 7373
Equal Opportunity Employment 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, veteran status, disability or any other legally protected status. If you require reasonable accommodation to complete any part of the application process, please contact jobs@syneoshealth.com.
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