Syneos Health is seeking a Principal Biostatistician specialized in Safety Surveillance and Real-World Evidence (RWE) to serve as a key statistical department resource. You will lead the statistical design and analysis for clinical trials and safety surveillance studies, ensuring high-quality deliverables and providing mentorship within the team.
What You'll Do
- Serve as a statistical department resource, mentor biostatisticians, and oversee or develop training plans.
- Prepare Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings, and figures.
- Manage the statistical aspects of the protocol, generation of randomization schedules, and input to clinical study reports.
- Review SAS annotated case report forms (CRFs), SAS database design, and other study documentation.
- Create or review programming specifications for analysis datasets, tables, listings, and figures.
- Direct the activities of other biostatistics personnel on assigned projects and provide independent review of their work.
- Serve as the biostatistics representative on project teams, interfacing with other departmental representatives.
- Conduct and participate in verification and quality control of project deliverables.
- Manage scheduling and time constraints across multiple projects and monitor progress against milestones.
- Provide statistical programming support as needed.
- May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
- Lead projects involving integrated analyses and support regulatory agency meetings.
- Provide input, review, and follow applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and regulatory guidelines.
- Maintain well-organized, complete, and up-to-date project documentation.
- Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
What We're Looking For
- Graduate degree in biostatistics or a related discipline.
- Extensive experience in clinical trials or an equivalent combination of education and experience.
- Experience with RW safety studies including healthcare claims knowledge.
- Required skills include: propensity score matching, knowledge and use of estimands, logistic regression, survival analysis, and incident rate understanding.
- Proficiency in programming.
- Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research.
- Excellent written and verbal communication skills.
- Ability to read, write, speak, and understand English.
Nice to Have
- Knowledge of Safety assessments including disproportionality analyses, statistical surveillance methods, safety risk modeling, data mining and AI/ML, signal detection and other safety assessment skills.
- Experience with regulatory submissions.
Technical Stack
- SAS
Team & Environment
Serves as the biostatistics representative on project teams.
Benefits & Compensation
- Compensation range: $95,000.00 - $175,700.00
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
Work Mode
This is a local-country position open to candidates across North America.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
