Principal Biostatistician

Principal Biostatistician (Biomarker Analyst -EMEA and US BASED)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

• Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics and devices) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statistician
• Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects
• Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects
• Conducts and designs advanced data analysis for genomics and biomarker statistics, including statistical programming, and design complex analysis algorithms
• Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results
• Works independently at routine and complex statistical questions and tasks
• Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments
• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work and provides independent review of project work
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures; collaborates with sponsor if required
• May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures
• Reviews SAS annotated CRFs, database design, and other study documentation to ensure protocol criteria are met and all data is captured as required
• Implements company objectives, and creates alternative solutions to address business and operational challenges
• Interfaces with other departmental project team representatives as biostatistics representative on project teams
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others
• Conducts verification and quality control of project deliverables, ensuring output meets expected results
• May lead complex or multiple projects (e.g., submissions, integrated analyses) and attend regulatory agency meetings or respond to questions to support the statistical analysis results
• Manages scheduling and time constraints across multiple projects, communicates timelines, and escalates issues as needed
• Monitors progress on study activities against milestones and ensures deliverables meet timelines
• Provides statistical programming support as needed
• May participate in DSMB/DMC activities, including charter development and serving as an independent non-voting biostatistician
• Provides input and follows applicable SOPs, WIs, and regulatory guidelines (e.g., ICH)
• Maintains organized project documentation and verification/quality control documents; ensures inspection readiness
• Assists with projects and initiatives to meet business needs
• Supports business development activities by contributing to proposals, budgets, and sponsor bid defenses
• Performs other work-related duties as assigned
• Minimal travel may be required

• Strong knowledge on Biomarker evaluation, especially in Oncology, ctDNA data, relevant parameters and underlying biology
• Graduate degree in biostatistics or related discipline
• Extensive experience in clinical trials or equivalent, demonstrated by ability to lead multiple projects
• Proficiency in programming
• Ability to apply extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques used in clinical research
• Experience across all statistical tasks to support clinical trials lifecycle from protocol to CSR
• Experience with regulatory submissions preferred
• Excellent written and verbal communication skills
• Ability to read, write, speak, and understand English

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Additional information about the company policies, responsibilities and equal opportunity statements are included in official job postings.

Tasks, duties and responsibilities listed in this description are not exhaustive. The Company may assign additional tasks at its sole discretion. Equal opportunity statements and required compliance information are maintained as per company policy.