Senior Biostatistician

Job Purpose

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.

Key Responsibilities

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.

Required Education

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

Required Skills and Experience

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 strong command of regulatory expectations in pharmaceutical development. You have significant experience contributing to major regulatory submissions, such as NDA, MAA or equivalent dossiers, and responding to health authority questions.

Technical Competencies

You have strong working knowledge of GCP, CDISC standards and relevant regulatory guidance, with a consistent focus on data integrity and reproducibility.
You have advanced SAS skills and the judgement to select, explain and defend appropriate statistical methods. Experience with additional statistical technologies and evolving analytical approaches is an advantage

Required Behaviours and Competencies

You are a credible and collaborative senior professional who communicates complex concepts with clarity and influence. You are comfortable operating with autonomy, making sound judgements, navigating ambiguity and engaging effectively at all levels of the organisation. You contribute positively to team effectiveness through expertise, constructive challenge and knowledge sharing.

Required Languages

Fluent written and spoken English; additional languages are an advantage in an international environment.

Salary

Gross Annual Salary starting from: 65.000€
Please note: The salary indicated in this posting complies with local pay transparency regulations for Italian employment contracts. Final offers will be tailored to the successful candidate's experience, professional expertise, and interview journey, while ensuring internal equity. At Recordati, we are committed to a comprehensive, fair, and competitive remuneration system; a full overview of your total rewards package will be shared and discussed with you during the recruiting process.