Director Biostatistics

Jan 12, 2022

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.

As the Director Biostatistics, you will influence and drives statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) within (pre/early/full) clinical development and/or medical affairs. You will lead and integrate input from different quantitative scientists impacting clinical development, health authority interactions, represent the biostatistics function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions to the organization.

• Ensure expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with pricing agencies, influence and implement publication strategy, quantitative decision making) for critical studies in a program
• Strategic statistical input and influence into one or more pro jects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).
• Lead collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans
• Collaborate cross-functionally (e.g. data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables
• Propose and implement innovative designs and methods to optimize drug development.
• Plan, prioritize and oversee project level activities and ensure efficient re source management within or across franchise and effective partnership with vendors.
• Lead the review and implementation of health authority guidances.
• Represent biostatistics in interacting with external experts (statistical, clinical, and technical).

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:
• MS (in Statistics or equivalent) with 12+ years relevant work experience or PhD (in Statistics or equivalent) with 8+ years relevant work experience.
• Has advanced knowledge of applying statistics and innovative approaches Expert knowledge in a variety of statistical areas.
• Record of successful implementation of novel methods and/or innovative strategies in drug development
• Extensive knowledge of drug development and HA guidelines
• Strong understating of at least one disease area
• Fluent English (oral and written)
• Strong interpersonal and communication skills bridging scientific and business needs

• Proven people leadership ability and expert skills in building partnerships and collaborations.
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.

Why consider Novartis?
769 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!
Global Drug Development
Cambridge, MA
Research & Development
Full Time
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Director Biostatistics

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