Sr​/Pr Biostatistician; Europe - Oncology

Updated:
Yesterday

Location:

DEU-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.

• Provide support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepare Statistical Analysis Plans (SAPs) and develop well‑presented mock‑up displays for tables, listings, and figures; collaborate with the sponsor as required.
• Manage statistical aspects of the protocol, including generation of randomization schedules, publications, and input to the clinical study report.
• Coordinate the activities of biostatistics and statistical programming personnel on assigned projects to ensure timely, high‑quality work.
• Perform independent review of project work produced by other biostatisticians.
• Review programming specifications for analysis datasets, tables, listings, and figures.
• Review SAS‑annotated CRFs, database design and other study documentation to ensure protocol criteria are met.
• Conduct verification and quality control of project deliverables, ensuring outputs meet expectations and are consistent with the SAP and specifications.
• Implement company objectives and develop alternative solutions to address business and operational challenges.
• Serve as the biostatistics representative on project teams, interfacing with other departmental representatives and preparing for internal meetings.
• Manage scheduling and time constraints across multiple projects, setting priorities and communicating any difficulties to biostatistics management.
• Monitor progress on study activities against agreed milestones and ensure delivery timelines are met; identify out‑of‑scope tasks and raise issues to management.
• Provide statistical programming support as needed.
• Participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non‑voting biostatistician.
• Lead projects involving integrated analyses, attend regulatory agency meetings, and respond to questions to support the statistical analysis results of clinical trials.
• Follow applicable SOPs, work instructions and regulatory guidelines (e.g., ICH).
• Maintain well‑organized, complete, and up‑to‑date project documentation, verification/quality‑control documents and programs to ensure inspection readiness.
• Display willingness to work with others and assist with projects and initiatives as necessary.
• Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Coach and mentor other biostatistics staff.
• Perform other work‑related duties as assigned.
• Travel may be required minimally.

• Previous lead experience within Oncology is required.
• Position open to Europe only.

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, disability status or any other protected class. If you are an individual with a disability who requires reasonable accommodation, please contact: