Principal Biostatistician (Medical Affairs) Europe and NA Based

Overview

Principal Biostatistician (Medical Affairs) Europe and NA Based – Syneos Health. Lead experience within Medical Affairs in a clinical trial setting is required. The role supports statistical activities across the lifecycle of clinical trials, contributes to proposals and budgets, and may participate in regulatory submissions and DSMB/DMC activities. Located in NA or Europe locations as posted.

Responsibilities

• Serve as a statistical department resource, mentor biostatisticians, and develop training plans or materials for Biostatistics associates; conduct training sessions for new hires and skill enhancement.
• Direct activities of biostatistics personnel on assigned projects to ensure timely, high-quality work; provide independent review of project work.
• Provide support across all statistical tasks during the project lifecycle (protocol to CSR).
• Prepare or oversee Statistical Analysis Plans (SAPs) and develop mock-up displays for tables, listings, and figures; collaborate with sponsor as required.
• Lead statistical aspects of the protocol, randomization schedule, and input to the clinical study report when applicable.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review SAS annotated CRFs, database design, and other study documentation to ensure data capture supports a high-quality database and planned analyses.
• Implement company objectives and propose alternative solutions to address business and operational challenges.
• Act as biostatistics representative on project teams; interface with other departmental project team members.
• Prepare for internal meetings, contribute ideas, and show respect for colleagues’ opinions.
• Conduct verification and quality control of project deliverables to ensure alignment with SAP and specifications.
• May lead complex projects (e.g., submissions, integrated analyses) and attend regulatory agency meetings or respond to questions to support statistical results for the sponsor.
• Manage scheduling and time constraints across multiple projects; communicate timelines and progress to management and adapt to changes.
• Monitor study activity milestones and ensure deliverables meet timelines; identify out-of-scope tasks and escalate as needed.
• Provide statistical programming support as needed.
• Possible participation in DSMB/DMC activities, including charter development; may serve as independent or voting statistician as required.
• Follow applicable SOPs, WIs, and regulatory guidelines (e.g., ICH); maintain organized project documentation and ensure inspection readiness.
• Collaborate with others and support business development activities by contributing to proposals and sponsor bid defenses.
• Perform other duties as assigned; minimal travel may be required.

Qualifications

• Graduate degree in biostatistics or related discipline.
• Extensive experience in clinical trials or equivalent, with ability to lead multiple projects/programs.
• Proficiency in programming; ability to apply extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques in clinical research.
• Experience across all statistical tasks from protocol to CSR; regulatory submission experience preferred.
• Excellent written and verbal communication skills; English proficiency.

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. We work to place the customer and patient at the center of everything we do, and we are committed to developing our people and fostering a diverse, inclusive culture.

For more information, visit http://www.syneoshealth.com