Description
Syneos Health is seeking a Principal Statistician to work on rare diseases phase III and IV projects. The successful candidate will serve as a statistical department resource, mentor biostatisticians, and oversee training plans or materials for Biostatistics associates.
Key responsibilities include:
- Directing the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work
- Providing independent review of project work produced by other biostatisticians in the department
- Preparing or overseeing the preparation of Statistical Analysis Plans (SAPs)
- Collaborating with sponsors, if required
- Creating or reviewing programming specifications for analysis datasets, tables, listings, and figures
- Reviewing SAS/R annotated case report forms (CRFs), database design, and other study documentation
- Implementing company objectives and creating alternative solutions to address business and operational challenges
- Interfacing with other departmental project team representatives
- Conducting and participating in verification and quality control of project deliverables
- Managing scheduling and time constraints across multiple projects
- Monitoring progress on study activities against agreed-upon milestones
- Providing statistical programming support as needed
- Participating in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities
- Maintaining well-organized, complete, and up-to-date project documentation
- Displaying willingness to work with others and assisting with projects and initiatives as necessary
Requirements:
- Graduate degree in biostatistics or related discipline
- Extensive experience in clinical trials or an equivalent combination of education and experience
- Proficiency in R 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
- Excellent written and verbal communication skills
- Ability to read, write, speak, and understand English