Principal Statistician – Ophthalmology
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Job Description
Principal Statistician leading biostatistical analyses for ophthalmology clinical trials at Syneos Health. Mentoring statisticians, overseeing SAPs, programming specifications, quality control, and regulatory support.
Responsibilities:
- Serves as a statistical department resource and mentors biostatisticians
- Oversees or develops training plans and materials; conducts training sessions
- Directs activities of biostatistics personnel on assigned projects and independently reviews project work
- Supports statistical tasks throughout the project lifecycle, from protocol to CSR
- Prepares or oversees Statistical Analysis Plans and mock-up displays
- May serve as Lead Biostatistician for protocol statistics, randomization schedules, and clinical study reports
- Creates or reviews programming specifications for analysis datasets, tables, listings, and figures
- Reviews SAS/R annotated CRFs, database design, and study documentation
- Interfaces with departmental project team representatives
- Conducts verification and quality control of project deliverables
- May lead complex or multiple projects and support regulatory agency meetings or questions
- Manages schedules, priorities, timelines, milestones, and out-of-scope task escalation
- Provides statistical programming support as needed
- May participate in DSMB/DMC activities
- Follows applicable SOPs, WIs, and regulatory guidelines such as ICH
- Maintains complete, current project and quality-control documentation for inspection readiness
- Supports business development through proposals, budgets, and sponsor bid defense meetings
- Performs other assigned work-related duties
Requirements:
- Graduate degree in biostatistics or related discipline
- Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies
- Proficiency in R programming
- Extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research
- Ability to effectively communicate statistical concepts
- Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR
- Experience with regulatory submissions preferred
- Excellent written and verbal communication skills
- Ability to read, write, speak, and understand English
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Minimal travel may be required
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