Principal Biostatistician

Principal Biostatistician (Biomarker Analyst – EMEA and US BASED) Updated: August 1, 2025Location: Madrid, Spain Overview 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. Job Responsibilities Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics and devices) of clinical studies or biomarker studies as 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, 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 advanced data analysis for genomics and biomarker statistics, including statistical programming, and designs 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. Provides independent review of project work produced by other biostatisticians in the department. Provides support across all statistical tasks during the lifecycle of the project, from protocol to Clinical Study Report. Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. 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 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 the biostatistics representative on project teams. Conducts verification and quality control of project deliverables to ensure that output meets the expected results and is consistent with analysis described in the SAP and specifications. Leads complex or multiple projects, attends regulatory agency meetings, or responds to questions to support the statistical analysis results of clinical trials on behalf of the sponsor. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and communicates proactively with biostatistics management. Monitors progress on study activities against agreed milestones and ensures the study timelines for project deliverables are met. Provides statistical programming support as needed. Participates in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. Provides input and reviews, and follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation and verification/quality control documents and programs, ensuring inspection readiness. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Performs other work-related duties as assigned. Minimally travels may be required. Qualifications 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 an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies. Proficiency in programming. Ability to apply extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to Clinical Study Report. Experience with regulatory submissions preferred. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign additional duties at its discretion. Equivalent experience, skills, and/or education will be considered for qualification differences. 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. All obligations imposed by the legislation of each country in which we operate are fully complied with, including the implementation of the EU Equality Directive. Get to know Syneos Health No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health at #J-18808-Ljbffr