Principal Biostatistician - Biomarker

Accountabilities:

• Lead the statistical planning, execution, analysis, and interpretation of biomarker and genomics components within clinical studies and research programs.


• Develop comprehensive Biomarker Evaluation Plans, ensuring consistency and scientific rigor across projects and study phases.


• Provide expert statistical input into clinical development strategies, biomarker research initiatives, and the application of AI and machine learning methodologies.


• Design and conduct advanced analyses of complex biomarker datasets, including genomics, transcriptomics, RNA, Olink, and other high-dimensional biological data.


• Develop innovative statistical methodologies, analytical frameworks, and algorithms to support biomarker discovery and validation.


• Coordinate biomarker-related statistical activities across cross-functional teams, ensuring alignment of objectives and deliverables.


• Oversee the preparation, quality, and interpretation of Biomarker Evaluation Reports and other key statistical deliverables.


• Contribute to the development and implementation of standardized processes, best practices, and analytical approaches for biomarker assessments.


• Collaborate closely with clinical, scientific, and operational stakeholders to support study objectives and data-driven decision-making.

Requirements

• PhD or MSc in Biostatistics, Statistics, Mathematics, or a related quantitative scientific discipline.


• Proven experience independently leading biomarker-focused studies within clinical research or drug development environments.


• Strong expertise in biomarker evaluation, particularly within immunology, infectious diseases, type 1 diabetes, or related therapeutic areas.


• Extensive experience analyzing complex, high-dimensional biological and genomic datasets.


• Proficiency in statistical programming using R, including Bioconductor and other relevant genomics packages, as well as Python.


• Experience working with RNA sequencing, Olink platforms, and other biomarker technologies.


• Knowledge of AI and machine learning methodologies and their application within biomarker research and clinical development.


• Strong understanding of clinical trial design, statistical methodologies, and regulatory expectations in life sciences.


• Excellent communication, presentation, and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.


• Demonstrated ability to work independently, manage complex projects, and provide scientific leadership with minimal supervision.


• Previous pharmaceutical, biotechnology, CRO, or clinical research industry experience is strongly preferred.

• Fully remote position with flexibility across the EMEA region.


• Opportunity to work on innovative biomarker and genomics research that supports the development of life-changing therapies.


• Access to ongoing professional development, technical training, and career advancement opportunities.


• Collaborative environment with highly experienced scientific, clinical, and statistical professionals.


• Exposure to cutting-edge technologies, including advanced analytics, AI, machine learning, and precision medicine initiatives.


• Comprehensive rewards and recognition programs.


• Inclusive and diverse workplace culture focused on collaboration, innovation, and professional growth.


• Global project exposure across multiple therapeutic areas and international clinical development programs.


• Supportive leadership and access to extensive scientific and operational resources.

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