Principal Biostatistician; Biomarker Analyst -EMEA

Description

Principal Biostatistician (Biomarker Analyst – EMEA & US Based)

Lead the biomarker strategy and provide statistical expertise throughout the lifecycle of clinical studies, from protocol development to the Clinical Study Report.

• Collaborate with cross‑functional teams to plan, execute, and analyze all biomarker aspects of studies, acting as the biomarker statistician under guidance of an experienced statistician.
• Develop the Biomarker Evaluation Plan, ensuring consistency within and between projects.
• Facilitate coordination of statistical activities for biomarker research and development.
• Conduct advanced data analysis for genomics and biomarker statistics, including statistical programming and design of complex analysis algorithms.
• Assume responsibility for the production and accuracy of the Biomarker Evaluation Report.
• Work independently on routine and complex statistical questions and tasks.
• Develop and implement standard processes for routine biomarker assessments.
• Mentor biostatisticians, provide training sessions, and develop training materials.
• Direct the activities of other biostatisticians on assigned projects and review their work for quality and timely completion.
• Support all statistical tasks across the project lifecycle, from protocol to CSR.
• Prepare or oversee Statistical Analysis Plans (SAPs) and create mock‑up displays for tables, listings, and figures.
• Lead statistical aspects of the protocol, randomization schedule, and contribute to the CSR.
• Create and review programming specifications for analysis datasets, tables, listings, and figures.
• Review CRFs, database design, and study documentation to ensure protocol criteria are met.
• Design alternative solutions to address business and operational challenges.
• Act as the biostatistics representative on project teams and interface with other departmental teams.
• Prepare for internal meetings, contribute ideas, and demonstrate respect for others’ opinions.
• Conduct and participate in verification and quality control of deliverables, ensuring consistency with the SAP and specifications.
• Lead complex or multiple projects, attend regulatory agency meetings, and respond to questions as needed.
• Manage scheduling and time constraints across multiple projects, set priorities, and communicate any issues to management.
• Monitor progress against milestones and ensure study timelines for deliverables are met.
• Provide statistical programming support as needed.
• Participate in DSMB/DMC activities, including charter development and independent/non‑voting roles.
• Follow applicable SOPs, WIs, and regulatory guidelines such as ICH.
• Maintain organized, up‑to‑date project documentation and inspection readiness.
• Assist with business development activities, including proposals, budgets, and sponsor bid defense meetings.
• Perform other work‑related duties as assigned.
• Minimal travel may be required.

• Graduate degree in biostatistics or a related discipline.
• Extensive experience in clinical trials (or equivalent education and experience) demonstrating the ability to lead multiple projects.
• Proficiency in programming (e.g., SAS).
• Strong knowledge of biomarker evaluation, particularly in Oncology, ctDNA data, and underlying biology.
• Ability to apply statistical design, analysis, regulatory guidelines, and programming techniques in clinical research.
• Experience with all statistical tasks from protocol to CSR.
• Experience with regulatory submissions preferred.
• Excellent written and verbal communication skills.
• Proficiency in English (reading, writing, speaking).

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. It also complies with the EU Equality Directive and all relevant employment legislation.