Principal Biostatistician (Medical Affairs - North America & Europe)
Syneos Health, Inc., Hartford, Connecticut, United States
Principal Biostatistician – Medical Affairs (North America & Europe)
Syneos Health® is a leading integrated biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs and commercial insights into outcomes that address modern market realities. This role is based remotely in the United States and requires residency in Europe or North America.
Job Responsibilities
Serve as a statistical department resource, mentor biostatisticians on job skills, and oversee or develop training plans or materials for Biostatistics associates.
Prepare Statistical Analysis Plans (SAPs), including presentation of mock‑up displays for tables, listings, and figures.
Manage the statistical aspects of protocols, 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 satisfy protocol criteria and capture data for high‑quality database and planned analysis.
Create or review programming specifications for analytical datasets, tables, listings, and figures.
Direct other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work and provide 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.
Represent the biostatistics function on project teams, interface with other departmental project team representatives, prepare in advance for internal meetings, and contribute ideas while demonstrating respect for the opinions of others.
Conduct verification and quality control of project deliverables, ensuring consistency with SAP and specifications.
Manage scheduling and time constraints across multiple projects, communicate progress, and adapt to timeline or priority changes by reorganizing daily workload.
Provide statistical programming support as needed and 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.
Lead projects involving integrated analyses and attend regulatory agency meetings or respond to questions to support statistical analysis results of clinical trials on behalf of the sponsor.
Maintain well‑organized, complete, and up‑to‑date project documentation and verification/quality control documents to ensure inspection readiness.
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
Previous lead experience within Medical Affairs is required.
Ph.D. is required.
Residency in Europe or North America is required.
Strong statistical programming background with proficiency in SAS and biostatistics best practices.
Excellent communication, mentoring, and project management skills.
Benefits
Competitive base salary within the Syneos Health range.
Health benefits including medical, dental, and vision.
Company match 401(k) and eligibility to participate in the Employee Stock Purchase Plan.
Eligibility to earn commissions/bonus based on company and individual performance.
Flexible paid time off (PTO) and sick time; paid sick time eligibility may vary by state.
Opportunity to work in a diverse, inclusive, and authentic workplace that values continuous learning and innovation.
Equal Opportunity Statement 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. 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.
Contact Phone: 919‑876‑9300 Fax: 919‑876‑9360 Toll‑Free: 866‑462‑7373 Email: jobs@syneoshealth.com Website: www.syneoshealth.com
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 qualifications, skills, competencies, and proficiency for the role.
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.
Legal Compliance All employment actions comply with the Americans with Disabilities Act and other applicable federal, state, and local laws. Syneos Health is committed to compliance with the EU Equality Directive and related regulations in the countries where it operates.
#J-18808-Ljbffr
Job Responsibilities
Serve as a statistical department resource, mentor biostatisticians on job skills, and oversee or develop training plans or materials for Biostatistics associates.
Prepare Statistical Analysis Plans (SAPs), including presentation of mock‑up displays for tables, listings, and figures.
Manage the statistical aspects of protocols, 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 satisfy protocol criteria and capture data for high‑quality database and planned analysis.
Create or review programming specifications for analytical datasets, tables, listings, and figures.
Direct other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work and provide 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.
Represent the biostatistics function on project teams, interface with other departmental project team representatives, prepare in advance for internal meetings, and contribute ideas while demonstrating respect for the opinions of others.
Conduct verification and quality control of project deliverables, ensuring consistency with SAP and specifications.
Manage scheduling and time constraints across multiple projects, communicate progress, and adapt to timeline or priority changes by reorganizing daily workload.
Provide statistical programming support as needed and 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.
Lead projects involving integrated analyses and attend regulatory agency meetings or respond to questions to support statistical analysis results of clinical trials on behalf of the sponsor.
Maintain well‑organized, complete, and up‑to‑date project documentation and verification/quality control documents to ensure inspection readiness.
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
Previous lead experience within Medical Affairs is required.
Ph.D. is required.
Residency in Europe or North America is required.
Strong statistical programming background with proficiency in SAS and biostatistics best practices.
Excellent communication, mentoring, and project management skills.
Benefits
Competitive base salary within the Syneos Health range.
Health benefits including medical, dental, and vision.
Company match 401(k) and eligibility to participate in the Employee Stock Purchase Plan.
Eligibility to earn commissions/bonus based on company and individual performance.
Flexible paid time off (PTO) and sick time; paid sick time eligibility may vary by state.
Opportunity to work in a diverse, inclusive, and authentic workplace that values continuous learning and innovation.
Equal Opportunity Statement 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. 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.
Contact Phone: 919‑876‑9300 Fax: 919‑876‑9360 Toll‑Free: 866‑462‑7373 Email: jobs@syneoshealth.com Website: www.syneoshealth.com
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 qualifications, skills, competencies, and proficiency for the role.
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.
Legal Compliance All employment actions comply with the Americans with Disabilities Act and other applicable federal, state, and local laws. Syneos Health is committed to compliance with the EU Equality Directive and related regulations in the countries where it operates.
#J-18808-Ljbffr