Job Description
This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require 1% travel as defined by the business (domestic and/ or international).
200+ compounds are supported by the quantitative drug developers in 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. In this role, 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 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
Your Key Responsibilities: (include but are not limited to):
• In collaboration with cross-functional quantitative partners, provide quantitative, scientific and strategic input to the integrated precision medicine biomarker strategies in clinical-stage 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
• Hands-on analysis and modeling 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.
• Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of modeling 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.
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
Role Requirements:
• PhD with 6+ years or MS with 10+ years, with a degree in bioinformatics, statistics, data science or other quantitative discipline and extensive exposure to bioinformatics and drug development with relevant work in the pharma/biotech industry.
• Strong knowledge and understanding of statistical methods such as meta-analysis, mixed effect modeling, longitudinal modeling, time to event (particularly survival) analysis, Bayesian methods, bagging/boosting, variable selection methods (e.g., lasso, elastic net, random forest), design of experiments. Experience with evidence generation and outcomes modeling in regulated clinical development/trials (as opposed to preclinical development) preferred.
• 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.) especially in the context of predictive modeling in drug development
• Strong programming skills in R and Python. Demonstrated knowledge of data visualization, exploratory analysis and predictive modeling.
• Good interpersonal and communication skills (written and verbal); demonstrated experience working effectively on a multidisciplinary team in a matrix organization. Experience with influencing diverse stakeholders in a cross-functional, interdisciplinary environment.
• 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
• Ability to develop and deliver clear and concise presentations for both internal and external meetings in key decision-making situations
Desirable Requirements:
• Experience in the application of bioinformatics methods and evidence to drug development
• Good understanding of clinical study design principles and familiarity working with clinical data in a clinical trial setting
• Knowledge of scripting languages, Perl, Python, with expertise in big data, web-based applications, good coding practice, source code management (Git, bitbucket)
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
https://www.novartis.com/careers/benefits-rewards
Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $192,000 – $288,000/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. 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