Mar 29, 2022

Job Description

1 in 10,000 is the frequency of a rare safety event! The science of detecting, quantifying and communicating adverse drug reactions as well as designing measurable risk minimization activities – this is quantitative safety science. Providing patients with more benefits than risks is Novartis top priority.

As Senior Expert Quantitative Safety Statistician you will craft the quantitative safety strategy for multiple programs in different therapeutic areas during the whole drug life cycle.

Responsibilities will include but are not limited to:
• Setting innovative scientific and functional standards for excellence in signal detection and assessment to evaluate the safety and benefit-risk assessments of assigned programs
• Providing strategic direction and statistical expertise to collection, evaluation, and presentation of safety data (from clinical trials, real world data, etc.) ensuring a holistic, efficient, and consistent approach
• Integrating input from different quantitative scientists as well as medical functions to impact the analytic strategy for clinical development and health authority interactions
• Coordinating quantitative safety activities for high quality objective-oriented health authority interactions, both written and verbal
• Leading global scientific improvement and change initiatives providing strategic, technical, operational, and scientific solutions to the organization

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:
• University degree in statistics or mathematics or related area (PhD preferred)
• 10+ years of experience in positions with growing responsibility in the Pharmaceutical Industry; with 6+ years applying statistical methods to drug development and post-marketing safety
• Expert knowledge and substantial experience of statistical methods applied to drug development and post-marketing safety and benefit-risk assessments with impact on company and/or health authority decisions.
• Demonstrated experience in developing and evaluating modern quantitative safety methodologies. Computing ability and experience with different data sources.
• Demonstrated contribution to external white-papers/policy shaping best practice in statistical science and experience in leading scientific improvement/ change initiatives
• Scientific curiosity combined with strong communication skills bridging scientific and business needs over different expertise areas
• Excellent strategic skills. Natural leadership style with the ability to build successful partnerships at all levels
• Some restrictions may apply on flexible working and will be discussed at interview it applicable

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. 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.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:


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.

Global Drug Development
East Hanover, NJ
Research & Development
Full Time
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Sr Expert Quantitative Safety Statistician

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