[Hiring] Principal Biostatistician Medical Affairs @Syneos Health

Role Description

The Principal Biostatistician in Medical Affairs will provide support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.

• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
• 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.
• Provides independent review of project work produced by other biostatisticians in the department.
• 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.
• Conducts and participates in verification and quality control of project deliverables.
• 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.
• Monitors progress on study activities against agreed-upon milestones.
• 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 and attend regulatory agency meetings.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
• Maintains well-organized, complete, and up-to-date project documentation.
• Displays willingness to work with others and assists with projects and initiatives as necessary.
• Supports business development activities by contributing to proposals and budgets.
• Coaches and mentors other Biostatistics staff.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Qualifications

• Previous clinical experience within Clinical Trials required.
• Must be located in UK, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, Belgium, Netherlands, France.

Requirements

• Strong statistical analysis skills.
• Experience with SAS programming.
• Ability to manage multiple projects and deadlines.
• Excellent communication and interpersonal skills.

Benefits

• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Inclusive culture where you can authentically be yourself.