Contribute to data reusability for metadata analysis and Reverse Translation. Champion reproducible research and traceability best practices; partner with Biomarker Data Management and Programming to ensure ALCOA++ compliance and conformance for regulatory interactions, where required. purpose lakehouse/warehouse patterns used widely in life sciences.Mentor, influence, and represent. Provide thought leadership in Biomarker analysis and data strategy, collaborate with statistics partners, and contribute to regulatory meetings as needed—consistent with senior biostatistics leadership responsibilities. Advanced degree in Biostatistics, Biomedical Science, Bioengineering, or related quantitative field; 8+ pharma/biotech experience spanning clinical development. Expert R & Bioconductor (package ecosystem fluency; writing robust, reproducible, tested code); Python for scientific computing and machine learning; SAS proficiency is valued. Expertise in surrogate markers, diagnostic, prognostic, pharmacodynamic and response predictive biomarker methods is a must; experience with regulatory strategies utilizing biomarkers a plusCommunication: clear statistical writing, and the ability to translate complex findings for crossDeep experience in statistical methods for Biomarker data, including feature engineering, dimensionality reduction, longitudinal modeling, survival analysis, multiplicity adjustment, and robust inference in highon experience in machine learning (classification, clustering, regularized models; ideally MLflowWorking experience with CDISC standards and submission metadata. Data & platform skills: Git, experience with Databricks/Snowflake; familiarity with data engineering patterns for analytics readiness, notion of CI/CD, containerization. Competitive salary package with extensive benefits.