Description
Syneos Health is seeking a Principal Biostatistician to lead projects across multiple studies or programs. As a Principal Biostatistician, you will act as the primary contact with the sponsor for all biostatistics related activities on assigned projects. You will provide external statistical consultancy for sponsor companies and serve as a departmental resource for complex statistical questions, study design considerations, and protocol development.
Responsibilities:
- Leads projects across multiple studies or programs
- Acts as primary contact with sponsor for biostatistics related activities
- Provides external statistical consultancy for sponsor companies
- Serves as departmental resource for complex statistical questions, study design considerations, and protocol development
- Mentors biostatisticians on job skills and oversees or develops training plans or materials
- Directs activities of other biostatistics personnel on assigned projects
- Provides independent review of project work produced by other biostatisticians
- Prepares or oversees preparation of Statistical Analysis Plans (SAPs)
- Collaborates with sponsor on SAPs and other statistical tasks
- 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
- Implements company objectives and creates alternative solutions to address business and operational challenges
- Interfaces with other departmental project team representatives
- Conducts and participates in verification and quality control of project deliverables
- May lead complex or multiple projects, including submissions and integrated analyses
- Manages scheduling and time constraints across multiple projects
- Monitors progress on study activities against agreed upon milestones
- Provides statistical programming support as needed
- Participates in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities
- 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, budgets, and attending sponsor bid defense meetings
Qualification Requirements:
- Graduate degree in biostatistics or related discipline (Master's degree minimum)
- Integrated analysis experience with hands-on experience with IASAP and TLF specifications
- Strong submission and clinical development expertise with deep understanding of clinical development plans and submission strategy
- Regulatory and cross-functional experience with ability to independently manage regulatory authority requests
- Extensive experience in clinical trials or equivalent combination of education and experience
- Proficiency in programming
- Ability to apply extensive knowledge of statistical design, analysis, and relevant regulatory guidelines
- Excellent written and verbal communication skills
- Ability to read, write, speak, and understand English