Senior Principal Biostatistician

• Location: Barcelona

About the job

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a SeniorPrincipal Biostatistician within our Clinical Statistics Team at Barcelona, you’ll leadseveral complex clinical studies (from phase I to IV)  or observational studies under minimum supervision of statistical project leader and/or team leader.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Support the clinical development plan (CDP), clinical study design (including protocol development and review), the study setup and conduct.
• Lead or Support submission activities such as ISS/ISE and CTD preparation & post-marketing commitment.
• Conduct / Oversee the execution of the statistical analyses according to the Statistical Analysis Plan, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
• Serve as a biostatistical consultant for other members of the department and staff members from other statistics department within the organization.
• Maintain knowledge and awareness of development in biostatistics and clinical trial methodology and regulatory requirements that impact on analysis.
• Accountable for all assigned statistical deliverables related to multiple complex studies or specific domains: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, Estimands etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables).
• Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure.
• Coordinate with study programmer the production and Qc of statistical analyses.
• Contribute to operation process optimization and provide inputs to statistics and quality standards.
• Represent statistics team to participate in scientific or technology working groups or cross function initiatives.

About you

Experience:

• 7+ years (MS) or 5+ years (PhD) of solid pharmaceutical industry experience in complex drug development
• Experience of project management and development preferred

Soft and technical skills:

• Broad knowledge and excellent understanding of advanced statistical concepts and techniques
• Demonstrated strong project/study management, interpersonal and communication skills
• Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences
• Extensive ability to apply advanced statistical analyses using SAS and R languages.
• Knowledge or experience with Artificial intelligence or Generative AI is a plus

Education:

• MS or PhD degree in Statistics or relevant fields

Languages:

• Highly effective communication in English, both oral and written.

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Build, develop and manage a statistics team support multiple TAs and different clinical phases.

Develop a career of being an influential statistician.

Gain international clinical trial experiences and communicate with Health Authorities worldwide.

“Shape the future of healthcare, empower clinical advancements as a visionary leader in a leading multinational pharmaceutical company”

PursueProgress. Discover Extraordinary.

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.