342025BR
Apr 13, 2022
USA

Job Description

200+ compounds in Novartis are supported by biostatisticians in 10+ sites around the globe. Biostatisticians transform clinical data into analyses that build the basis for making innovative drugs accessible for patients. They influence decision-making in cross-functional international teams from early to late phase drug development.

In the Statistical Methodology team, we work as internal consultants to support our drug development portfolio across all development phases and disease areas. The Associate Director, Statistical Methodology is a lead contributor at the Trial and Project level, working in collaboration with other members in the Analytics organization (biostatisticians, pharmacometricians) and Global Project Teams to ensure the use of state-of-the-art statistical methods, models and machine learning. You will participate actively in the professional development of biostatistics and pharmacometrics group members. In addition, you will play a strong supporting role in driving scientific collaborations across academia, industry and regulators to advance innovative quantitative drug development methodologies.

Your responsibilities include but are not limited to:
• Lead project support requiring hands-on expertise in novel quantitative approaches. This could include: innovative complex clinical trial designs, quantitative decision making, incorporating evidence from trial external sources or big data (e.g. historical data, real world data, biomarkers, digital technology etc.), causal inference etc.
• Lead collaborative working relationships and effective communication with partners in the Analytics organization along with the clinical team to promote and implement innovative quantitative approaches at project level
• Implement and communicate innovative quantitative methods to support regulatory submissions and health authority meetings
• Support the use of advanced analytical support to improve Development Unit level decision making, including support for key development decision points (DDP, FDP and SDP), transition of projects from research to development, quantitative aspects of dose-finding, clinical development plan and target product profile, portfolio level evaluation and the assessment of in-licensing opportunities
• Help develop communication and training strategies at Development Unit level regarding specific use of advanced quantitative methodology
• Develop new quantitative methods with the aim of improving drug development at Novartis in multiple projects. The focus includes clinical trial design and analysis, quantitative decision making, statistical modeling, visualization and machine learning
• Provide training on quantitative methods to colleagues within the Analytics organization and other functions in clinical development
• Publish in peer reviewed journals, helps organizing sessions at external professional conferences and contribute to cross-industry work streams in external scientific working groups
• Involved in coaching and mentoring junior colleagues in the Analytics 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:
• Ph.D. in statistics, biostatistics, mathematics, data science, computational biology or another related field
• At least 6 years of experience with application of innovative quantitative methods in drug development setting
• Expert knowledge in a number of relevant quantitative approaches in terms of both theory and hands-on experience
• Scientific leadership skills demonstrated in facilitating and optimizing the (early/full) clinical development strategy by using expertise in design, modeling or analytics
• Fluent English oral and written
• Good interpersonal and communication skills (verbal and written) bridging scientific and business needs. In particular, the ability to effectively represent quantitative issues to clinical teams
• Solid experience with mentoring of junior associates
• Track record of scientific publications and training courses given in the area of quantitative sciences

769 million. That’s how many lives our products touch. At Novartis, being there when and how it matters most for our patients and customers allows us to live our purpose and help bring maximum impact to health outcomes.

Furthering our commitment to transforming medicine for patients, Novartis is embarking on an ambitious and exciting journey to reinvent how we use technology, data and customer insights to better serve our consumer’s needs and put them on a path to better health. This includes taking bold approaches that begin with a customer-centric mindset and harness the power of today’s digital and data-driven healthcare revolution to continue to improve and extend even more people’s lives.

• Do you want to help people understand their disease and how to seek out the proper treatment for it?
• Do you want to support patients achieve the best possible outcomes?
• Do you want to deliver a leading customer experience at all touchpoints?
• Do you want to be at the forefront of leveraging today’s technology advances to create tomorrow’s healthcare innovations?

We believe the answers are found when curious, adventurous, and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to utilize the power of digital and data to individualize and maximize interactions with customers. Where you’re empowered to not fear failure when taking smart risks. And most importantly, where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
CD&A GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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342025BR

Associate Director, Statistical Methodology

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