Senior Principal Biostatistician

<h1><b>Senior Principal Biostatistician</b></h1><h1></h1><ul><li><i>Location: Barcelona</i></li></ul><h2></h2><h2><b><span><span>About the job</span></span></b></h2><p></p><p><span><span>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 </span><b><span>Senior</span></b><span> </span><b><span>Principal Biostatistician</span></b><span> within our Clinical Statistics Team at Barcelona, you’ll lead</span></span> <span><span>several complex clinical studies (from phase I to IV)  or observational studies under minimum supervision of statistical project leader and/or team leader.</span></span></p><p><span><span> </span></span></p><p><span><span>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?</span></span></p><p></p><h3><span><span> </span></span></h3><h3><span><b><span>Main responsibilities:</span></b></span></h3><p><span><span> </span></span></p><ul><li><span><span>Support the clinical development plan (CDP), clinical study design (including protocol development and review), the study setup and conduct.</span></span></li><li><span><span>Lead or Support submission activities such as ISS/ISE and CTD preparation &amp; post-marketing commitment.</span></span></li><li><span><span>Conduct / Oversee the execution of the statistical analyses according to the Statistical Analysis Plan, prepare statistical methods &amp; 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.</span></span></li><li><span><span>Serve as a biostatistical consultant for other members of the department and staff members from other statistics department within the organization.</span></span></li><li><span><span>Maintain knowledge and awareness of development in biostatistics and clinical trial methodology and regulatory requirements that impact on analysis.</span></span></li><li><span><span>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).</span></span></li><li><span><span>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.</span></span></li><li><span><span>Coordinate with study programmer the production and Qc of statistical analyses.</span></span></li><li><span><span>Contribute to operation process optimization and provide inputs to statistics and quality standards.</span></span></li><li><span><span>Represent statistics team to participate in scientific or technology working groups or cross function initiatives.</span></span></li></ul><p></p><p></p><h3><b><span><i><span>About you</span></i></span></b></h3><p></p><h3><span><b><span>Experience</span></b><span>:</span></span></h3><ul><li><span><span>7+ years (MS) or 5+ years (PhD) of solid pharmaceutical industry experience in complex drug development</span></span></li><li><span><span>Experience of project management and development preferred</span></span></li></ul><p></p><h3><span><b><span>Soft and technical skills</span></b><span>:</span></span></h3><ul><li><span><span>Broad knowledge and excellent understanding of advanced statistical concepts and techniques</span></span></li><li><span><span>Demonstrated strong project/study management, interpersonal and communication skills</span></span></li><li><span><span>Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences</span></span></li><li><span><span>Extensive ability to apply advanced statistical analyses using SAS and R languages.</span></span></li><li><span><span>Knowledge or experience with Artificial intelligence or Generative AI is a plus</span></span></li></ul><p></p><h3><span><b><span>Education</span></b><span>: </span></span></h3><ul><li><span><span>MS or PhD degree in Statistics or relevant fields</span></span></li></ul><p></p><h3><span><b><span>Languages</span></b><span>:</span></span></h3><ul><li><h3><span><span>Highly effective communication in English, both oral and written.</spa