Associate Director, Data Science (Biomarker, Omics)
The Early Development Analytics group is searching for an Associate Director Data Scientist. As the successful candidate, you will drive the biomarker strategy for early and late development clinical programs in multiple indications or a disease area, working closely with interdisciplinary teams to analyze and interpret biomarker data to inform critical project decisions and understand mechanisms of response/resistance to therapy. You will be responsible for designing and executing the biomarker strategy in those programs to inform drug development, and you will set the strategy for addressing biomarker issues in early/late phase trials, regulatory submissions and directly influence drug development decisions with internal and external partners.
What you’ll be doing: Your responsibilities include, but are not limited to:
• In collaboration with cross-functional quantitative partners, provide quantitative, scientific and strategic input to support the execution of the integrated precision medicine biomarker strategies in drug development.
• Contribute to planning, execution, interpretation, and communication of innovative exploratory biomarker analyses, to facilitate internal decision making, publications and support submissions of candidate drug and associated companion diagnostics packages
• Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required.
• Represent the Analytics line functions on cross-functional teams for the assigned projects. Responsible for functional alignment and ensuring line function awareness throughout the assigned activities
• Independently lead interactions with external parties (e.g., key opinion leaders, health authorities) with oversight as appropriate, and represent Novartis in statistical discussions at external congresses, conferences and scientific meetings
• Drive and promote the use of innovative approaches within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings
• Lead or contribute to departmental initiatives (e.g., infrastructure/ process-related or scientific activities)
• Contribute to the scientific content of materials for internal decision boards/regulatory/submission documents: Briefing Books, decision criteria, trial design(s), responses to Health Authority questions.
• Hands-on analysis of clinical and high-dimensional biomarker data from clinical trials (genomics, transciptomics, proteomics, flow cytometry etc.) to generate fit-for-purpose evidence that is applied for decision making in drug development programs.
This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position may require 1% travel as defined by the business (domestic and/ or international).