Principal Biostatistician (RWE, HEOR) - North America, Europe
Syneos Health, Inc., Nashville, Tennessee, United States
Updated:
October 23, 2025 Location:
USA-TN-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 places the customer and the patient at the center of everything we do. We continuously simplify and streamline our work so that Syneos Health is easier to work with and easier to work for. WORK HERE MATTERS EVERYWHERE
Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. Why Syneos Health
We are passionate about developing our people through career development, supportive 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 unites us globally and we are dedicated to taking care of our people. We continually build the company we all want to work for and the customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels they belong. Job Responsibilities
Experience with a variety of RWD including eHR, registry studies, pharmacy data, etc., as well as clinical trial experience. Experience with real‑world safety studies, including healthcare claims knowledge. Required skills: 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, AI/ML, signal detection and other safety assessment skills. General Experience & Qualifications
Serves as a statistical department resource, mentors biostatisticians, oversees or develops training plans or materials for biostatistics associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel. Prepares Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures. Collaborates with sponsors as required. Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report. Reviews SAS annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high‑quality database and the planned analysis. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Directs activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work and provides independent review of project work produced by other statisticians. Implements company objectives, creates alternative solutions to address business and operational challenges, serves as biostatistics representative on project teams, and interfaces with other departmental project team representatives. Conducts verification and quality control of project deliverables, manages scheduling and time constraints across multiple projects, and proactively communicates with biostatistics management. Provides statistical programming support as needed and may participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities. Leads projects involving integrated analyses, attends regulatory agency meetings, and supports the statistical analysis results of clinical trials on behalf of the sponsor. Maintains well‑organized, complete, and up‑to‑date project documentation and ensures inspection readiness. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Performs other work‑related duties as assigned. Minimal travel may be required. Graduate degree in biostatistics or related discipline. Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrating the 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 Benefits
Benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), company match 401(k), 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. Get to know Syneos Health
Over the past 5 years, Syneos Health has worked with 94% of all novel FDA‑approved drugs, 95% of EMA‑authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients. 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. Contact
Phone: 919‑876‑9300 Fax: 919‑876‑9360 Toll‑Free: 866‑462‑7373 Email: jobs@syneoshealth.com Equal Opportunity Employer
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 and will not be discriminated against. 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.
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October 23, 2025 Location:
USA-TN-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 places the customer and the patient at the center of everything we do. We continuously simplify and streamline our work so that Syneos Health is easier to work with and easier to work for. WORK HERE MATTERS EVERYWHERE
Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. Why Syneos Health
We are passionate about developing our people through career development, supportive 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 unites us globally and we are dedicated to taking care of our people. We continually build the company we all want to work for and the customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels they belong. Job Responsibilities
Experience with a variety of RWD including eHR, registry studies, pharmacy data, etc., as well as clinical trial experience. Experience with real‑world safety studies, including healthcare claims knowledge. Required skills: 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, AI/ML, signal detection and other safety assessment skills. General Experience & Qualifications
Serves as a statistical department resource, mentors biostatisticians, oversees or develops training plans or materials for biostatistics associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel. Prepares Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures. Collaborates with sponsors as required. Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report. Reviews SAS annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high‑quality database and the planned analysis. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Directs activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work and provides independent review of project work produced by other statisticians. Implements company objectives, creates alternative solutions to address business and operational challenges, serves as biostatistics representative on project teams, and interfaces with other departmental project team representatives. Conducts verification and quality control of project deliverables, manages scheduling and time constraints across multiple projects, and proactively communicates with biostatistics management. Provides statistical programming support as needed and may participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities. Leads projects involving integrated analyses, attends regulatory agency meetings, and supports the statistical analysis results of clinical trials on behalf of the sponsor. Maintains well‑organized, complete, and up‑to‑date project documentation and ensures inspection readiness. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Performs other work‑related duties as assigned. Minimal travel may be required. Graduate degree in biostatistics or related discipline. Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrating the 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 Benefits
Benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), company match 401(k), 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. Get to know Syneos Health
Over the past 5 years, Syneos Health has worked with 94% of all novel FDA‑approved drugs, 95% of EMA‑authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients. 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. Contact
Phone: 919‑876‑9300 Fax: 919‑876‑9360 Toll‑Free: 866‑462‑7373 Email: jobs@syneoshealth.com Equal Opportunity Employer
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 and will not be discriminated against. 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.
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