Senior Biostatistician

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

We are seeking an experienced Senior Biostatistician to provide expert methodological support across the development portfolio. The role will ensure the robust management, analysis and interpretation of data from studies of new and marketed medicines conducted directly or through CROs, including integrated and pooled analyses. The successful candidate will contribute to statistical strategy, promote contemporary methods and technologies, and support consistently high statistical standards across R&D.

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• You will collaborate closely with Therapeutic Area management to define robust statistical approaches to clinical trials, translate scientific questions into evidence plans and support the operational requirements of clinical development programmes.
  
• You will play an influential role in cross-functional Project Teams, providing clear statistical direction, constructively challenging assumptions and enabling evidence-based decisions throughout the development lifecycle.
  
• You will be accountable, directly or through oversight, for high-quality statistical input to major documents, including clinical development plans, protocols, data management plans, case report forms, clinical study reports, integrated summaries of safety and efficacy, scientific publications and external data presentations. You will partner with Medical Writing and other functions to ensure scientific clarity, consistency and regulatory readiness.
  
• You will lead or supervise the development of statistical analysis plans and the production of tables, figures and listings, ensuring that approaches are scientifically rigorous, efficient and fit for purpose.
  
• You will provide expert review of clinical study protocols and statistical and data management documents, setting a high standard for quality and consistency.
  
• You will lead complex analyses and interpretation of results from clinical studies, integrated analyses and meta-analyses, communicating implications clearly to cross-functional and senior stakeholders.
  
• You will maintain sufficient hands‑on SAS expertise to perform or critically review statistical analyses, tables, figures and listings, while effectively overseeing programming delivered by internal or external partners.
  
• You will build effective partnerships with Medical and Clinical functions to plan analyses, interpret study data and resolve complex methodological questions.
  
• You will partner with R&D Quality Assurance in audits of CROs and study sites and help ensure the integrity, traceability and quality of statistical analyses.
  
• You will collaborate with Drug Safety on the statistical evaluation of pharmacovigilance data, including signal detection activities.
  
• You will contribute to the development, implementation, maintenance and continuous improvement of divisional SOPs, standards and guidelines.
  
• You will provide risk‑based oversight of CRO statistical deliverables, proactively managing quality, timelines, dependencies and escalation of issues.
  
• You will champion the evaluation and responsible adoption of new statistical methods, tools and technologies, share expertise and contribute to consistent, high‑quality statistical practices across the function.
  

Advanced degree in Statistics, Biostatistics, Mathematics or a closely related quantitative discipline; a PhD is advantageous but not essential.

Typically 10 or more years of progressive biostatistics experience in the pharmaceutical industry, biotechnology sector or a CRO, with substantial responsibility for clinical development programmes.
You bring deep expertise in theoretical and applied statistics and a s