Syneos Health is hiring a Principal Biostatistician to serve as a key statistical department resource and lead for our Early Phase clinical trials. This role is critical for directing statistical activities to ensure timely, high-quality deliverables while mentoring team members. Syneos Health is dedicated to taking care of our people and creating a place where everyone feels they belong.
What You'll Do
- Serve as a statistical department resource, mentor biostatisticians, and oversee or develop training plans.
- Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work.
- Provide support across all statistical tasks during the lifecycle of the project, from protocol to Clinical Study Report (CSR).
- Prepare or oversee the preparation of Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings, and figures.
- Act as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedules, 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.
- Interface with other departmental project team representatives as the biostatistics lead on project teams.
- Conduct and participate in verification and quality control of project deliverables.
- Lead complex or multiple projects, such as submissions or integrated analyses, and may attend regulatory agency meetings.
- Manage scheduling and time constraints across multiple projects, proactively communicating timeline difficulties.
- Monitor progress on study activities against agreed milestones.
- Provide statistical programming support as needed.
- Participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.
- Provide input and reviews, and subsequently follow applicable SOPs, Work Instructions, and relevant 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.
- Proficiency in programming.
- Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research.
- Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
- Excellent written and verbal communication skills.
- Ability to read, write, speak, and understand English.
- Must be located in North America, UK, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, South Africa, Argentina, Mexico, Brazil, or Colombia.
Nice to Have
- Experience with regulatory submissions.
Technical Stack
- SAS
Work Mode
This is a fully remote position open to candidates located in North America, UK, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, South Africa, Argentina, Mexico, Brazil, or Colombia.
Syneos Health is an equal opportunity employer.
