Director Biostatistics

Job Description Summary

The Director, SMC is an expert contributor at the Project and Franchise level, working in collaboration with Biostatisticians, Pharmacometricians and Global Project Teams to ensure the use of state of the art statistical methods, models and machine learning. Must be able to influence and drive quantitative innovation in drug development across indications / therapeutic areas. Leading professional development of Biostatistics and Pharmacometrics group members. In addition, this person plays a significant role in driving scientific collaborations across academia, industry and regulators to advance drug development methodologies.

Job Description

Key requirements:

• Leads project support requiring hands-on expertise in novel quantitative approaches. This could include: innovative clinical trial design, quantitative decision making, incorporating evidence from sources of big data (e.g. biomarkers, digital technology and real world evidence)
• Establishes and leads collaborative working relationships and effective communication with Biostatistics & Pharmacometrics partners along with clinical team to promote and implement innovation at project level
• Provides agile consulting, guidance and non-standard exploratory analysis for unplanned urgent drug project critical problems. Takes leadership in implementation and communication of innovative quantitative methods to support regulatory submissions and health authority meetings
• Leads the use of advanced analytical support to improve Franchise level decision making, including support for key development decision points), 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.
• Fosters and develops new quantitative methods with the aim of improving drug development at Novartis in multiple projects. The focus includes clinical trial design, modeling, visualization and machine learning
• Actively evaluates the need of technology and novel scientific software, visualization tools and new approaches to computation to increase efficiency and quality of the Novartis drug development practices and ensure the proper implementation meeting timelines.
• Provides training on quantitative methods to colleagues within Biostatistics, Pharmacometrics and other functions in clinical development.
• Collaborates actively with regulatory, academic and industry partner to advance drug development science through innovative quantitative approaches

Your Experience:

• Ph.D. in statistics, biostatistics, data science, computational biology or another related field
• Excellent communication skills, fluency in English and strong presentation skills
• At least 8 years of experience with application of innovative quantitative methods in drug development setting
• Strong expert knowledge in several relevant quantitative approaches in terms of both theory and hands-on experience
• Strong scientific leadership skills demonstrated in facilitating and optimizing the (early/full) clinical development strategy by using expertise in design, modelling or analytics.
• Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs. In particular, the ability to effectively represent quantitative issues to clinical teams.
• Track record of impactful scientific publications and training courses given in the area of quantitative science.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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.

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Skills Desired

Automation, Biostatistics, Clinical Trials, Computer Programming, Cross-Functional Teams, Data Analytics, Data Strategy, Decision Making Skills, Global Project Management, Metadata Management, Statistical Analysis