Company Overview
This company has a world-class team leveraging technology and artificial intelligence to advance cancer care through a platform that ingests real-time healthcare data to enable personalized diagnostics. Their solutions support research, clinical development and commercialization across the biotech industry.
The Biostatistics team plays a central role in transforming large-scale real-world and clinical oncology data into actionable evidence that advances precision medicine. The team partners closely with data science, clinical development, and regulatory stakeholders to design studies, develop statistical approaches, and ensure rigorous analysis across the product and research lifecycle. Biostatisticians here support a broad range of initiatives. This is a highly collaborative, science-driven environment where statistical expertise directly impacts the understanding of disease and the advancement of personalized cancer care.
• Build and lead a high-performance team of biostatisticians with expertise in various aspects of statistics, clinical trial design, and data analysis. Provide expert conceptual and methodological leadership and collaborate with stakeholders through the design and conduct of retrospective validation studies
• Lead development on statistical analysis plan (SAP) for sponsored interventional and observational studies and propose accurate and efficient statistical methodologies.
• Drive the strategy and delivery of key analytical or clinical components of regulatory submissions, including Q-subs, TAs, PMAs, and sPMAs.
• Serve as a Representative with regulatory authorities for all things Biostatistics.
• Collaborate with data scientists, laboratory science and regulatory teams on study design, planning, data preparation, programming, analysis and presentation of data.
• Ph.D. or Masters Degree in Biostatistics, Statistics, or a related field
• 7+ years relevant industry experience.
• Proven experience working with Real World Data and its applications in clinical research.
• Experience with the analysis of RWD studies (e.g. using claims, EHR or registry data sources)
• You have experience with SOPs development.
• Demonstrated leadership experience with oversight of biostatisticians, to include and training and development.
• Thorough understanding of statistical principles and clinical experiment methodology.
• Experience working in oncology and/or cardiology clinical trials.
• Familiarity with machine learning techniques and predictive and prognostic algorithms in medical research.
• Experience in cancer genetics, immunology, molecular biology, or similar
