Overview

We are seeking a highly motivated Associate Director of Biostatistics in Early Development. You will partner with a pharmacometrician and other quantitative scientists to influence and drive the quantitative strategy and innovation through strong collaborations contributing to an integrated drug development plan and design, execution, and decision making for assigned trials/programs within early clinical development. This role involves providing statistical leadership to support complex clinical trials and leading strategy through collaboration across the organization. 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 therapeutic area depth and platform capabilities to bring medicines to patients faster. We are seeking key talent to help give people with disease and their families a brighter future to look forward to.

Role

Representing the Early Development Analytics function on decision boards, developing and mentoring other quantitative scientists, and providing solutions to the organization.

Responsibilities

• Responsible for all statistical tasks on assigned clinical trials, including high-complexity trials with a high level of independence, seeking peer input/review as required. Responsible for protocol development aligned with the development plan, developing the statistical analysis plan (SAP), and reporting activities.
• Contribute to planning and execution of exploratory analyses, innovative analyses related to publications, PK, PK/PD analyses, exploratory biomarkers, and statistical consultation. Initiate, drive, and implement novel methods and innovative trial designs and dose-finding strategies.
• Provide statistical expertise to support clinical pharmacology submission activities, including documents, responses to Health Authorities, and drug development activities, as required.
• Independently lead interactions with external review boards/ethics committees, external consultants, and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings.
• Represent the Early Development Analytics Function on cross-functional teams for assigned trials. Ensure functional alignment and line-function awareness throughout the trials.
• Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions when required.
• Establish and maintain sound working relationships and effective communication within the clinical trial team and with other Biostatistics & Pharmacometrics team members.
• Independent oversight of Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.

Qualifications

• MS in Statistics with work experience or PhD (in Statistics or equivalent) with work experience.
• Fluent in English with strong communication and presentation skills, with the ability to articulate complex concepts to diverse audiences.
• Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support the department in delivering objectives.
• Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require expertise in pharmacokinetics, exposure–response modelling, exploratory biomarker analysis, applied Bayesian statistics, or data exploration skills. Demonstrated excellence in SAS, R; strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve objectives. Expertise in facilitating and maximizing the contribution of a quantitative team. Hands-on experience in leading early clinical development campaigns.
• Strong understanding of early development. Demonstrated leadership in facilitating and optimizing early-clinical development strategy. Track record of global scientific leadership in modern program/trial design methodologies. Familiarity with pharmacometric principles is a plus.
• Demonstrated strong skills in building partnerships and collaborations. Ability to mentor up to 8 junior associates.

Why Novartis

Commitment to diversity and inclusion: Novartis is committed to building an outstanding, inclusive work environment and a diverse team representative of the patients and communities we serve. Consider joining our Talent Network to stay connected and learn about suitable career opportunities as they come up.

Additional Information

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