Principal Biostatistician (RWE, HEOR) - North America, Europe
Syneos Health, Inc., New York, New York, United States
Updated:
October 23, 2025
Location:
USA-GA-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 that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
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. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE 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 total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. When we bring 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; healthcare claims knowledge is critical.
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 will be useful.
General Experience
Serves as a statistical department resource, mentors biostatisticians, oversees or develops training plans or materials for Biostatistics associates, and conducts training sessions for new hires and existing personnel.
Prepares Statistical Analysis Plans (SAPs), including mock‑up displays for tables, listings, and figures; collaborates with sponsor if 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 data is captured to support a high‑quality database and planned analysis.
Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work; provides independent review of project work produced by other statisticians.
Implements company objectives and creates alternative solutions to address business and operational challenges.
Serves as biostatistics representative on project teams and interfaces with other departmental project team representatives; prepares for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
Conducts and participates in verification and quality control of project deliverables, ensuring output meets expected results and is consistent with analysis described in SAP and specifications.
Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes, and proactively communicates difficulties to biostatistics management.
Provides statistical programming support as needed.
May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non‑voting or voting biostatistician.
Leads projects involving integrated analyses, attends regulatory agency meetings or responds to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
Provides input and reviews, and subsequently follows applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant regulatory guidelines (e.g., ICH).
Maintains well‑organized, complete, and up‑to‑date project documentation and verification/quality control documents and programs; ensures inspection readiness.
Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
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.
Qualifications
Graduate degree in biostatistics or related discipline.
Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by 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 communicate statistical concepts effectively.
Experience with regulatory submissions preferred.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
Benefits We reward and recognize our people by providing a range of benefits, including a company car or car allowance, health benefits covering 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. Eligibility for paid sick time may vary depending on location.
Salary Range:
$95,000.00 - $175,700.00
Get to Know Syneos Health Over the past 5 years, we have 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.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health at http://www.syneoshealth.com.
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Syneos Health is dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Syneos Health® (Nasdaq: SYNH) is a leading 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.
Phone: 919 876 9300 Fax: 919 876 9360 Toll‑Free: 866 462 7373
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, 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. One of our staff members will work with you to provide alternate means to submit your application.
#J-18808-Ljbffr
October 23, 2025
Location:
USA-GA-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 that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
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. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE 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 total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. When we bring 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; healthcare claims knowledge is critical.
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 will be useful.
General Experience
Serves as a statistical department resource, mentors biostatisticians, oversees or develops training plans or materials for Biostatistics associates, and conducts training sessions for new hires and existing personnel.
Prepares Statistical Analysis Plans (SAPs), including mock‑up displays for tables, listings, and figures; collaborates with sponsor if 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 data is captured to support a high‑quality database and planned analysis.
Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work; provides independent review of project work produced by other statisticians.
Implements company objectives and creates alternative solutions to address business and operational challenges.
Serves as biostatistics representative on project teams and interfaces with other departmental project team representatives; prepares for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
Conducts and participates in verification and quality control of project deliverables, ensuring output meets expected results and is consistent with analysis described in SAP and specifications.
Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes, and proactively communicates difficulties to biostatistics management.
Provides statistical programming support as needed.
May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non‑voting or voting biostatistician.
Leads projects involving integrated analyses, attends regulatory agency meetings or responds to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
Provides input and reviews, and subsequently follows applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant regulatory guidelines (e.g., ICH).
Maintains well‑organized, complete, and up‑to‑date project documentation and verification/quality control documents and programs; ensures inspection readiness.
Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
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.
Qualifications
Graduate degree in biostatistics or related discipline.
Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by 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 communicate statistical concepts effectively.
Experience with regulatory submissions preferred.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
Benefits We reward and recognize our people by providing a range of benefits, including a company car or car allowance, health benefits covering 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. Eligibility for paid sick time may vary depending on location.
Salary Range:
$95,000.00 - $175,700.00
Get to Know Syneos Health Over the past 5 years, we have 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.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health at http://www.syneoshealth.com.
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Syneos Health is dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Syneos Health® (Nasdaq: SYNH) is a leading 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.
Phone: 919 876 9300 Fax: 919 876 9360 Toll‑Free: 866 462 7373
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, 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. One of our staff members will work with you to provide alternate means to submit your application.
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