Associate Director Biostatistics Early Development

Novartis; London; Hybrid; GBP 80,000 - 120,000; Full time

Job summary

A leading company reimagining medicine is seeking an Associate Director of Biostatistics to drive innovative strategies and collaborate on early clinical development. The role requires strong expertise in biostatistics and experience in managing complex clinical trials. This position offers a hybrid working model and a commitment to diversity within a collaborative environment.

Qualifications

• 10+ years experience required with MS or 6+ years with PhD.
• Fluent in English with strong communication skills.
• Experience with innovative statistical methods and drug development.

Responsibilities

• Responsible for statistical tasks on clinical trials.
• Lead interactions with external review boards.
• Oversee biostatistics resources and deliverables.

Skills

Automation

Biostatistics

Clinical Trials

Programming

Data Analytics

Decision Making

Metadata Management

Statistical Analysis

Education

MS in Statistics

PhD in Statistics

Tools

SAS

R

Job description

Job Description Summary

We are seeking a highly motivated Associate Director of Biostatistics in Early Development; you will partner with pharmacometricians and other quantitative scientists to influence and drive the quantitative strategy and innovation. This role involves collaboration in integrated drug development plans, trial design, execution, and decision-making within early clinical development. Proven experience in supporting complex clinical trials and leading strategic initiatives across organizations is essential.

Job Description

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.

We are optimizing our processes, investing in new technologies, and building capabilities in specific therapeutic areas to bring medicines to patients faster.

We seek talented individuals like you to join us and help give people with diseases and their families a brighter future.

Apply today and become part of a collaborative environment!

The Role:

Representing the Early Development Analytics function internally and externally, developing and mentoring quantitative scientists, and providing innovative solutions.

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

Key Responsibilities:

1. Responsible for all statistical tasks on assigned clinical trials, including protocol development, statistical analysis plans, and reporting activities, especially for high-complexity trials.
2. Contribute to exploratory analyses, publications, PK, PK/PD analyses, biomarker analyses, and innovative trial designs.
3. Provide statistical expertise for clinical pharmacology submissions, responses to health authorities, and drug development activities.
4. Lead interactions with external review boards, ethics committees, consultants, and represent Novartis at scientific meetings.
5. Participate in cross-functional teams, ensuring alignment and awareness throughout trials.
6. Collaborate with other functions, explain statistical concepts clearly, and provide sound statistical justifications.
7. Oversee biostatistics resources and deliverables, ensuring quality and timeliness.

Your Experience:

• MS in Statistics with 10+ years or PhD in Statistics with 6+ years of experience.
• Fluent in English with strong communication skills.
• Experience with innovative statistical methods and clinical trial applications.
• Expertise in statistical software (e.g., SAS, R), drug development, and regulatory guidelines.
• Leadership experience in multidisciplinary teams and early clinical development campaigns.
• Understanding of pharmacometric principles is a plus.

Why Novartis:

Join us to help people with diseases and their families through innovative science and a collaborative community. Create a brighter future together: https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

We strive to build an inclusive work environment reflecting the communities we serve.

Join our Talent Network: https://talentnetwork.novartis.com/network

Skills Desired:

Automation, Biostatistics, Clinical Trials, Programming, Data Analytics, Decision Making, Metadata Management, Statistical Analysis