Principal Biostatistician; Biomarker Analyst -EMEA

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…