Senior Principal Biostatistician

Sanofi

  • Barcelona
  • Permanente
  • Tiempo completo
  • Hace 14 días
Senior Principal Biostatistician
  • Location: Barcelona
About the jobOur 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 Senior Principal Biostatistician within our Clinical Statistics Team at Barcelona, you’ll lead several 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 youExperience:
  • 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”Pursue Progress. Discover Extraordinary.Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.#LI-Hybrid #BarcelonaHub #SanofiHubsPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !

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