Principal Data Scientist, Applied Clinical Biomarker Analytics(Omics)

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?

• Contribute to departmental initiatives (e.g., infrastructure/ process-related or scientific activities)
• 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.
• 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.
• 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
• 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.
• Promote the use of innovative approaches within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings
• 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

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).
EEO Statement
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:

• Good understanding of clinical study design principles and familiarity working with clinical data in a clinical trial setting is a must
• Ability to develop and deliver clear and concise presentations for both internal and external meetings in key decision-making situations.
• Ability to leverage technical and scientific information from a variety of sources in order to effectively enable data analysis and the scientific interpretation of analysis results
• Familiarity with statistical and analytical methods for genetics and -omics data analysis, and working knowledge of high dimensional exploratory biomarker platforms (e.g., next generation sequencing, transcriptomics, proteomics, flow cytometry, etc.) in an applied setting
• 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
• Strong programming skills in R and Python. Demonstrated knowledge of data visualization, exploratory analysis and predictive modeling.
• 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
• Good interpersonal and communication skills (verbal and writing), demonstrated experience working effectively on a multidisciplinary team in a matrix organization. Experience with influencing diverse stakeholders in a cross-functional, interdisciplinary environment.

Desirable:

• Knowledge of scripting languages such as Perl, Python, with expertise in big data, web-based applications, good coding practice, source code management (Git, bitbucket)
• Experience in the application of bioinformatics methods and evidence to drug development

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
The pay range for this position at commencement of employment is expected to be between $136,800-205,200 a year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Division
Global Drug Development
Business Unit
CD&A GDD
Country
USA
Work Location
Boston, MA
Company/Legal Entity
Novartis Pharmaceuticals
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No