Principal Biostatistician; Medical Affairs - North America & Europe

Updated: November 4, 2025
Location: USA-NC-Remote
Job :

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 not only make Syneos Health easier to work with, but to make us easier to work for.

On this role, you will collaborate with passionate problem solvers and innovate as a team to help our customers achieve their goals.

• We are passionate about developing our people through career development, supportive line management, technical and therapeutic training, peer recognition and a total rewards program.
• We are committed to a culture that welcomes authenticity and diversity, and we aim to create a place where everyone feels like they belong.
• We are continuously building the company we all want to work for and our customers want to work with.

• Lead experience within Medical Affairs is required; must be based in Europe or North America.
• PhD required.
• Serve as a statistical department resource, mentor biostatisticians, oversee training plans, conduct training sessions and enhance skills of personnel.
• Prepare Statistical Analysis Plans (SAPs) with mock‑up displays for tables, listings, and figures, and collaborate with sponsors as needed.
• Handle the statistical aspects of the protocol, generate randomization schedule and provide input to the clinical study report.
• Review SAS annotated CRFs, database design and other study documentation to ensure protocol criteria are met and data are captured for a high‑quality database and planned analysis.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Direct biostatistics personnel on assigned projects, provide independent reviews, and ensure timely, high‑quality work.
• Implement company objectives and devise alternative solutions to business and operational challenges.
• Act as the biostatistics representative on project teams, interfacing with other departmental representatives, preparing for meetings and demonstrating respect for others’ opinions.
• Conduct verification and quality control of project deliverables, ensuring outputs meet the expected results and align with SAP and specifications.
• Manage scheduling and time constraints across multiple projects, set goals, and communicate proactively with biostatistics management.
• Provide statistical programming support as needed and participate in DSMB and/or DMC activities, including charter development and serving as an independent or voting statistician.
• Lead integrated analyses projects, attend regulatory agency meetings, and support the statistical analysis results of clinical trials on behalf of sponsors.
• Follow applicable SOPs, work instructions, and regulatory guidelines (e.g., ICH). Maintain organized, up‑to‑date project documentation and verification/quality‑control documents.
• Assist with business‑development activities such as proposals, budgets and sponsor bid defense meetings.
• Perform other related duties as assigned and travel minimally may be required.

Benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), company 401(k) match, Employee Stock Purchase Plan eligibility, commissions/bonuses, flexible paid time off and sick time, and other benefits as per applicable state regulations.

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies, and proficiency.

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, veteran status, disability or any other legally protected status.