Join to apply for the Sr/Pr Biostatistician (Europe - Oncology) role at Syneos Health .
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes that address modern market realities.
About the Role
The Sr/Pr Biostatistician will provide statistical support throughout the lifecycle of clinical projects, collaborating with sponsors and cross-functional teams to ensure high-quality, regulatory‑compliant analyses.
Responsibilities
- Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to clinical study report.
- Prepares Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures.
- May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
- Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work and provides independent review of project work produced by other biostatisticians.
- Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
- Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
- Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
- Implements company objectives and creates alternative solutions to address business and operational challenges.
- Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives.
- Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
- Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met; identifies out‑of‑scope tasks and escalates to management.
- Provides statistical programming support as needed.
- May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities.
- May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
- Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
- Maintains well organized, complete, and up‑to‑date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
- Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
- Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
- Coaches and mentors other Biostatistics staff.
- Performs other work‑related duties as assigned.
- Minimal travel may be required.
Qualifications
- Previous lead experience within Oncology is required.
- This position is open to Europe only.
Company Culture & Benefits
- We are passionate about developing our people through career development, training, and total rewards.
- We are committed to a culture of authenticity, inclusion, and belonging.
- We continuously build a company that our customers and employees want to work with.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and responsibilities at its discretion. Equivalent experience, skills, and/or education may be considered. This description is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive and the Americans with Disabilities Act.
Summary
- Previous lead experience within Oncology is required.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
#J-18808-Ljbffr