Principal Biostatistician; Medical Affairs - North America & Europe

Updated:
November 4, 2025

Location:

USA-WA-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 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.

• 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.

• 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.

• Previous lead experience within Medical Affairs is required.
• Must be located in Europe or North America.
• Ph.D. required.

• Company car or car allowance.
• Health benefits:
  
  Medical, Dental, Vision.
• Company match 401(k).
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibil…