Principal Biostatistician (Medical Affairs - North America & Europe)
Syneos Health, Inc., Olympia, Washington, United States
Updated: November 4, 2025
Location: USA-WA-Remote
Job ID: 25102671
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, and we continually look for ways to simplify and streamline our work to be easier for clients and employees alike.
Whether you join us in a functional service‑provider partnership or a full‑service environment, you will collaborate passionately to help our customers achieve their goals in an agile, innovative way.
Why Syneos Health
We are passionate about developing our people through career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and a comprehensive total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. This culture unites us globally and ensures we take care of our people.
We continuously build the company we all want to work for and the customers want to work with by embracing diversity of thoughts, backgrounds, cultures, and perspectives, creating a place where everyone feels belonging.
Job Responsibilities
Serve as a statistical department resource, mentor biostatisticians on job skills, oversee or develop training plans or materials for biostatistics associates, and conduct training sessions.
Prepare Statistical Analysis Plans (SAPs), including mock‑up displays for tables, listings, and figures, and collaborate with sponsors when required.
Handle the statistical aspects of the protocol, including generation of the randomization schedule and input to the clinical study report.
Review SAS‑annotated CRFs, database design, and other documentation to ensure protocol criteria are met and all data is captured for high‑quality 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 and provide independent review of their work.
Implement company objectives and devise alternative solutions to address business and operational challenges.
Act as the biostatistics representative on project teams, interfacing with other departmental representatives, preparing for internal meetings, contributing ideas, and respecting others’ opinions.
Conduct and participate in verification and quality control of project deliverables, ensuring they meet expected results and align with SAP and specifications.
Manage scheduling and time constraints across multiple projects, set goals based on management priorities, communicate time, and adjust workloads proactively.
Offer statistical programming support as needed and may participate in DSMB and/or DMC activities, including charter development and serving as an independent non‑voting biostatistician. May serve as a voting statistician on these boards.
Lead projects involving integrated analyses, attend regulatory agency meetings, and respond to questions to support statistical analysis results of clinical trials on behalf of the sponsor.
Review and follow applicable SOPs, WIs, and regulatory guidelines (e.g., ICH). Maintain well‑organized, complete, and up‑to‑date project documentation and verification/quality‑control records, ensuring inspection readiness.
Assist with projects and initiatives as necessary to meet business needs, prepare for internal meetings, and support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
Perform other work‑related duties as assigned and provide statistical programming support where needed. Minimal travel may be required.
Qualifications
Previous lead experience within Medical Affairs is required.
Must be located in Europe or North America.
Ph.D. required.
Benefits
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/bonuses based on company and individual performance.
Flexible paid time off (PTO) and sick time, with compliance to applicable state and municipal paid sick time requirements.
Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on candidate’s qualifications, skills, and proficiency for the role.
EEO & Compliance 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. Syneos complies with the Americans with Disabilities Act and the EU Equality Directive and will provide reasonable accommodations as needed.
Contact Information: Phone: 919‑876‑9300 Fax: 919‑876‑9360 Toll‑Free: 866‑462‑7373 Website:
www.syneoshealth.com Email: jobs@syneoshealth.com
Apply today or join our Talent Network to stay connected to additional career opportunities.
#J-18808-Ljbffr
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, and we continually look for ways to simplify and streamline our work to be easier for clients and employees alike.
Whether you join us in a functional service‑provider partnership or a full‑service environment, you will collaborate passionately to help our customers achieve their goals in an agile, innovative way.
Why Syneos Health
We are passionate about developing our people through career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and a comprehensive total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. This culture unites us globally and ensures we take care of our people.
We continuously build the company we all want to work for and the customers want to work with by embracing diversity of thoughts, backgrounds, cultures, and perspectives, creating a place where everyone feels belonging.
Job Responsibilities
Serve as a statistical department resource, mentor biostatisticians on job skills, oversee or develop training plans or materials for biostatistics associates, and conduct training sessions.
Prepare Statistical Analysis Plans (SAPs), including mock‑up displays for tables, listings, and figures, and collaborate with sponsors when required.
Handle the statistical aspects of the protocol, including generation of the randomization schedule and input to the clinical study report.
Review SAS‑annotated CRFs, database design, and other documentation to ensure protocol criteria are met and all data is captured for high‑quality 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 and provide independent review of their work.
Implement company objectives and devise alternative solutions to address business and operational challenges.
Act as the biostatistics representative on project teams, interfacing with other departmental representatives, preparing for internal meetings, contributing ideas, and respecting others’ opinions.
Conduct and participate in verification and quality control of project deliverables, ensuring they meet expected results and align with SAP and specifications.
Manage scheduling and time constraints across multiple projects, set goals based on management priorities, communicate time, and adjust workloads proactively.
Offer statistical programming support as needed and may participate in DSMB and/or DMC activities, including charter development and serving as an independent non‑voting biostatistician. May serve as a voting statistician on these boards.
Lead projects involving integrated analyses, attend regulatory agency meetings, and respond to questions to support statistical analysis results of clinical trials on behalf of the sponsor.
Review and follow applicable SOPs, WIs, and regulatory guidelines (e.g., ICH). Maintain well‑organized, complete, and up‑to‑date project documentation and verification/quality‑control records, ensuring inspection readiness.
Assist with projects and initiatives as necessary to meet business needs, prepare for internal meetings, and support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
Perform other work‑related duties as assigned and provide statistical programming support where needed. Minimal travel may be required.
Qualifications
Previous lead experience within Medical Affairs is required.
Must be located in Europe or North America.
Ph.D. required.
Benefits
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/bonuses based on company and individual performance.
Flexible paid time off (PTO) and sick time, with compliance to applicable state and municipal paid sick time requirements.
Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on candidate’s qualifications, skills, and proficiency for the role.
EEO & Compliance 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. Syneos complies with the Americans with Disabilities Act and the EU Equality Directive and will provide reasonable accommodations as needed.
Contact Information: Phone: 919‑876‑9300 Fax: 919‑876‑9360 Toll‑Free: 866‑462‑7373 Website:
www.syneoshealth.com Email: jobs@syneoshealth.com
Apply today or join our Talent Network to stay connected to additional career opportunities.
#J-18808-Ljbffr