Principal Data Scientist, Applied Clinical Biomarker Analytics(omics)

Key Skills

Bitbucket, Data Analytics, Data science techniques, Design, Git, Perl Programming, Python Programming, R Programming

Job Description

200+ compounds are supported by the quantitative drug developers in Early Development Analytics at Novartis. We transform data from multiple sources - clinical, biomarker, digital sensor, imaging - into analyses and insights that build the basis for making innovative drugs accessible for patients. We influence decision-making in cross-functional international teams from early to late phase drug development.

The Early Development Analytics group is searching for a Principal Data Scientist. As the successful candidate, you will contribute to 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 delivering on the biomarker strategy in those programs to inform drug development, and you will help 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?

• In collaboration with cross-functional quantitative partners, provide quantitative, scientific 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
• Promote the use of innovative approaches within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings
• 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 or East Hanover, NJ 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).

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you’ll bring to the role:

• Advanced degree in bioinformatics, statistics, data science or other quantitative discipline with extensive exposure to bioinformatics and drug development. MS with 6+ years relevant work experience or PhD with 3+ years of relevant work experience in the pharma/biotech industry
• Good understanding of clinical study design principles and familiarity working with clinical data in a clinical trial setting is a must
• Strong knowledge and understanding of statistical methods such as meta-analysis, mixed effect modeling, longitudinal modeling, time to event analysis, Bayesian methods, bagging/boosting, variable selection methods (e.g., lasso, elastic net, random forest), design of experiments