Senior Principal Biostatistician Early Development

Summary

The Senior Principal Biostatistician in Early Development is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team.

About the Role

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.

This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office.

Key Responsibilities:

• Responsible for all statistical tasks on the assigned trials and perform these tasks for mid- to high complexity trials independently with peer review/input as required.
• Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities.
• Contribute to planning and execution of exploratory analyses, innovative analyses related to publications, PK, PK/PD analyses, exploratory biomarker, and statistical consultation.
• Explain statistical methodology and interpret analysis results.
• Provide statistical expertise to support clinical pharmacology submission activities and documents, responses to Health Authorities and drug development activities, as required.
• Collaborate with other line functions and explain statistical concepts in an easily understandable way to non-statisticians.
• Establish and maintain sound working relationships cross functionally within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
• Propose and implement innovative designs and methods to optimize dose finding and drug development.

Your Experience:

• MS Statistics with 10+ years’ work experience or PhD (in Statistics or equivalent) with 6 years + work experience.
• Fluent in English with strong communication and presentation skills.
• Proven knowledge and expertise in statistics and its application to clinical trials.
• Demonstrated excellence in use of statistical software packages (e.g. SAS, R).
• Strong understanding of early development. Familiarity with pharmacometric principles is a plus.
• Ability to mentor up to 8 junior associates.

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. Ready to create a brighter future together?

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.