Director Biostatistics (80-100%*)
Director Biostatistics (80-100%*)
Stellenbeschreibung200+ 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 our Director Biostatistics, you will influence and drive 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 be responsible for leading and integrating input from different quantitative scientists impacting, clinical development, health authority interactions. You will 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. Additionally, you may serve as:
• Global Program Biostatistics Head for a mid to high complexity project and/or Lead Statistician for multiple pre/early clinical/CP projects
• Global manager of a small team - Individual contributor who is a leader with vision in drug development biostatistics across related indications/areas
Your responsibilities will include:
• 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
• Accountable for strategic statistical input and influence into one or more projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).
• May be a core member of GPT representing Biostatistics and Pharmacometrics. 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.
• Effective partnership with other functions to ensure integrated quantitative in-put into project and collaborate cross-functionally (e.g. data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables.
• Plan, prioritize and coordinate project level activities and ensure efficient re-source management within or across development unit and effective partnership with vendors.
• Facilitate seamless transition of projects from early to late development.
• Propose and implement innovative designs and methods to optimize drug development.
• Represent Biostatistics and Pharmacometrics line function at internal and external decision boards (e.g. regulators).
Disease Area/TA/Indication level:
• As partner to senior clinical and scientific leadership, drive strategic statistical input and excellence to drug development within the TA/DA/indications.
Development Unit or Global Line Function level:
• Lead or significantly contribute to initiatives at global line function level, or cross-functional development unit level, requiring coordination of diverse of team members.
• Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives.
MindestanforderungenWhat you’ll bring to the role:
• MS or PhD in Biostatistics (or equivalent)
• Fluent English oral and written, excellent communication and presentation skills
• MS (in Statistics or equivalent) with 12+ years relevant work experience or PhD (in Statistics or equivalent) with 8+ years relevant work experience.
• Have 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 and a strong understating of at least one disease area
• May have proven people leadership ability and expert skills in building partnerships and collaborations.
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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!
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: https://talentnetwork.novartis.com/network
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.