Sr-Principal Biostatistician - Oncology (Europe Only)
Updated: Today
Location: Dublin, Ireland
Syneos Health is a leading fully integrated biopharmaceutical solutions organization.
We accelerate customer success by translating unique clinical, medical and commercial insights into outcomes.
Job Responsibilities
Serve as a statistical department resource, mentor biostatisticians on job skills, and oversee or develop training plans and materials for biostatistics associates.
Conduct training sessions, or otherwise train new hires and enhance the skills of existing personnel.
Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work.
Provide independent review of project work produced by other biostatisticians in the department.
Support all statistical tasks during the lifecycle of the project, from protocol to CSR.
Prepare or oversee the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings and figures.
Collaborate with sponsors as required.
Act as Lead Biostatistician for the statistical aspects of the protocol, generation of randomisation schedule and input to the clinical study report.
Create or review programming specifications for analysis datasets, tables, listings and figures.
Review SAS annotated case report forms (CRFs), database design and other study documentation to ensure protocol criteria are met.
Implement company objectives, creating alternative solutions to address business and operational challenges.
Serve as biostatistics representative on project teams, interface with other departmental project team representatives, prepare for internal meetings, contribute ideas and demonstrate respect for others' opinions.
Conduct verification and quality control of project deliverables, ensuring outputs meet the SAP and specifications.
Lead complex or multiple projects (e.g., submissions, integrated analyses), and attend regulatory agency meetings or respond to questions as needed.
Manage scheduling and time constraints across multiple projects, set goals, discuss time estimates, adapt workload, and communicate difficulties with meeting timelines.
Monitor progress against milestones and ensure timelines for project deliverables are met.
Identify out-of-scope tasks and escalated to management.
Provide statistical programming support as needed.
Participate in DSMB and/or DMC activities, including charter development and serving as an independent non-voting biostatistician; may serve as a voting statistician.
Provide input and reviews, and subsequently follow applicable SOPs, WIs and relevant regulatory guidelines (e.g., ICH).
Maintain organized, complete and up-to-date project documentation, verification/quality control documents and programs; ensuring inspection readiness.
Support business development activities by contributing to proposals, budgets and attending sponsor bid defense meetings.
Perform other work-related duties as assigned.
Travel may be required.
Requirements
Previous lead oncology experience within an industry setting.
Role is open to candidates located in Europe only.
Additional Information
Tasks, duties and responsibilities are not exhaustive.
The Company may assign other tasks, duties and job responsibilities at its discretion.
Equivalent experience, skills and/or education will be considered.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations.
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