Principal Biostatistician (RWE, HEOR) - North America, Europe
Syneos Health, Inc., Raleigh, North Carolina, United States
Updated:
October 23, 2025 Location:
USA-NC-Remote Job ID:
25102670
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 we do. We continuously look for ways to simplify and streamline our work so that Syneos Health is easier to work with and easier to work for.
Why Syneos Health
We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture brings us together globally, and we are dedicated to taking care of our people.
We continuously build the company we all want to work for and the customers want to work with. By bringing together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.
Job Responsibilities
Experience with a variety of RWD including eHR, registry studies, pharmacy data, etc., as well as CT experience.
Experience with RW safety studies, including healthcare claims knowledge.
Required skills include: propensity score matching, knowledge and use of estimands, logistic regression, survival analysis, incident rate understanding, etc.
Knowledge of safety assessments including disproportionality analyses, statistical surveillance methods, safety risk modeling, data mining and AI/ML, signal detection, and other safety assessment skills.
Serve as a statistical department resource, mentor biostatisticians on job skills, develop training plans or materials for biostatistics associates, and conduct training sessions for new hires and existing personnel.
Prepare Statistical Analysis Plans (SAPs), including well‑presented mock‑up displays for tables, listings, and figures; collaborate with sponsors as required.
Handle the statistical aspects of the protocol, generate randomization schedules, and contribute to the clinical study report.
Review SAS‑annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and data are captured as required for a high‑quality database and planned analysis.
Create or review programming specifications for analysis datasets, tables, listings, and figures.
Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work, providing independent review of project work produced by other statisticians in the department.
Implement company objectives and develop alternative solutions to address business and operational challenges.
Act as biostatistics representative on project teams, interface with other departmental project team representatives, prepare for internal meetings, contribute ideas, and demonstrate respect for others’ opinions.
Conduct and participate in verification and quality control of project deliverables, ensuring output meets the expected results and is consistent with analysis described in the SAP and specifications.
Manage scheduling and time constraints across multiple projects, set goals based on priorities from management, discuss time estimates for completion of study‑related activities with biostatistics management, adapt to timeline or priority changes by reorganizing daily workload, and proactively communicate to biostatistics management any difficulties with meeting timelines. Monitor progress on study activities against agreed milestones and ensure project deliverables have scheduled timelines met; identify out‑of‑scope tasks and escalates to management.
Provide statistical programming support as needed.
Possibly participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non‑voting biostatistician; may serve as a voting statistician on DSMBs and/or DMCs.
Lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions as needed to support the statistical analysis results of clinical trials on behalf of the sponsor.
Follow applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant regulatory guidelines (e.g., International Conference on Harmonization (ICH)).
Maintain well‑organized, complete, and up‑to‑date project documentation, verification/quality control documents, and programs to ensure inspection readiness.
Display willingness to work with others and assist with projects and initiatives as necessary to meet business needs.
Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for others’ opinions.
Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
Perform other work‑related duties as assigned.
Minimal travel may be required.
Qualifications
Graduate degree in biostatistics or a related discipline.
Extensive experience in clinical trials or an equivalent combination of education and experience, with demonstrated ability to lead multiple projects and programs of studies.
Proficiency in programming.
Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
Experience with regulatory submissions preferred.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
Salary Range: $95,000.00 - $175,700.00
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.
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, 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, please contact us at jobs@syneoshealth.com.
Phone: 919 876 9300 Fax: 919 876 9360 Toll‑Free: 866 462 7373
#J-18808-Ljbffr
October 23, 2025 Location:
USA-NC-Remote Job ID:
25102670
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 we do. We continuously look for ways to simplify and streamline our work so that Syneos Health is easier to work with and easier to work for.
Why Syneos Health
We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture brings us together globally, and we are dedicated to taking care of our people.
We continuously build the company we all want to work for and the customers want to work with. By bringing together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.
Job Responsibilities
Experience with a variety of RWD including eHR, registry studies, pharmacy data, etc., as well as CT experience.
Experience with RW safety studies, including healthcare claims knowledge.
Required skills include: propensity score matching, knowledge and use of estimands, logistic regression, survival analysis, incident rate understanding, etc.
Knowledge of safety assessments including disproportionality analyses, statistical surveillance methods, safety risk modeling, data mining and AI/ML, signal detection, and other safety assessment skills.
Serve as a statistical department resource, mentor biostatisticians on job skills, develop training plans or materials for biostatistics associates, and conduct training sessions for new hires and existing personnel.
Prepare Statistical Analysis Plans (SAPs), including well‑presented mock‑up displays for tables, listings, and figures; collaborate with sponsors as required.
Handle the statistical aspects of the protocol, generate randomization schedules, and contribute to the clinical study report.
Review SAS‑annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and data are captured as required for a high‑quality database and planned analysis.
Create or review programming specifications for analysis datasets, tables, listings, and figures.
Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work, providing independent review of project work produced by other statisticians in the department.
Implement company objectives and develop alternative solutions to address business and operational challenges.
Act as biostatistics representative on project teams, interface with other departmental project team representatives, prepare for internal meetings, contribute ideas, and demonstrate respect for others’ opinions.
Conduct and participate in verification and quality control of project deliverables, ensuring output meets the expected results and is consistent with analysis described in the SAP and specifications.
Manage scheduling and time constraints across multiple projects, set goals based on priorities from management, discuss time estimates for completion of study‑related activities with biostatistics management, adapt to timeline or priority changes by reorganizing daily workload, and proactively communicate to biostatistics management any difficulties with meeting timelines. Monitor progress on study activities against agreed milestones and ensure project deliverables have scheduled timelines met; identify out‑of‑scope tasks and escalates to management.
Provide statistical programming support as needed.
Possibly participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non‑voting biostatistician; may serve as a voting statistician on DSMBs and/or DMCs.
Lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions as needed to support the statistical analysis results of clinical trials on behalf of the sponsor.
Follow applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant regulatory guidelines (e.g., International Conference on Harmonization (ICH)).
Maintain well‑organized, complete, and up‑to‑date project documentation, verification/quality control documents, and programs to ensure inspection readiness.
Display willingness to work with others and assist with projects and initiatives as necessary to meet business needs.
Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for others’ opinions.
Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
Perform other work‑related duties as assigned.
Minimal travel may be required.
Qualifications
Graduate degree in biostatistics or a related discipline.
Extensive experience in clinical trials or an equivalent combination of education and experience, with demonstrated ability to lead multiple projects and programs of studies.
Proficiency in programming.
Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
Experience with regulatory submissions preferred.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
Salary Range: $95,000.00 - $175,700.00
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.
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, 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, please contact us at jobs@syneoshealth.com.
Phone: 919 876 9300 Fax: 919 876 9360 Toll‑Free: 866 462 7373
#J-18808-Ljbffr