Principal Statistician Oncology (Submission Experience)

About the role

Syneos Health is hiring a Principal Statistician Oncology with submission experience, working remotely. The role serves as a statistical department resource, mentoring biostatisticians and overseeing training, while directing the work of other biostatistics personnel on assigned projects. It covers the full statistical lifecycle of clinical trials, from protocol to CSR, and may include leading complex projects such as submissions and integrated analyses.

Key responsibilities

• Mentor biostatisticians, develop training plans and conduct training sessions for new hires and existing staff.
• Direct the work of other biostatisticians, provide independent review of their project work and support all statistical tasks from protocol to CSR.
• Prepare or oversee Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings and figures, and collaborate with the sponsor if required.
• Act as Lead Biostatistician for the statistical aspects of the protocol, randomization schedule and input to the clinical study report.
• Create or review programming specifications for analysis datasets, tables, listings and figures.
• Review SAS/R annotated CRFs, database design and other study documentation to ensure protocol criteria are met and data is captured correctly.
• Verify and quality control project deliverables against the SAP and specifications, and maintain organized, up-to-date project documentation for inspection readiness.
• Manage scheduling and time constraints across multiple projects, set goals, adapt to timeline changes and escalate out-of-scope tasks.
• Provide statistical programming support, prepare for internal meetings, and contribute to proposals, budgets and sponsor bid defenses.
• May lead complex or multiple projects, attend regulatory agency meetings, and may serve on DSMBs and/or DMCs, including as a voting statistician.
• Follow SOPs, WIs and regulatory guidelines (e.g. ICH); minimal travel may be required.

Required profile

• Graduate degree in biostatistics or a related discipline.
• Extensive clinical trial experience, demonstrated by the ability to lead multiple projects and programs of study.
• Experience across all statistical tasks from protocol to CSR; regulatory submission experience preferred.
• Excellent written and verbal communication skills and fluency in English.

Required skills

• Proficiency in programming.
• Knowledge of statistical design, analysis and regulatory guidelines used in clinical research.
• Ability to communicate statistical concepts clearly.