Principal Biostatistician (Biomarker Analyst -EMEA and US BASED)

Principal Biostatistician (Biomarker Analyst – EMEA and US BASED) 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 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 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 on 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; conducts training sessions or otherwise trains new hires and enhances the skills of existing personnel. 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 CSA. 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 case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high‑quality database and the planned analysis. Implements company objectives and creates alternative solutions to address business and operational challenges. As biostatistics representative on project teams, interfaces with other departmental project team representatives; prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications. May lead complex or multiple projects (e.g., submissions, integrated analyses), attend regulatory agency meetings or respond to questions, as needed, 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, discusses time estimates for completion of study‑related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed‑upon milestones and ensures the study timelines for project deliverables are met; identifies out‑of‑scope tasks and escalates to management. Provides statistical programming support as needed. May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non‑voting biostatistician; may serve as a voting statistician on DSMBs and/or DMCs. Provides input and reviews, and subsequently follows applicable SOPs, workflows, 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. Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid‑defense meetings. Performs other work‑related duties as assigned. Minimal travel may be required. Qualifications Strong knowledge of biomarker evaluation, especially in oncology, ctDNA data, relevant parameters, and underlying biology. Graduate degree in biostatistics or a 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, relevant 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 CSA. 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, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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. #J-18808-Ljbffr