Senior Biostatistician

Recordati; Milano; Ibrido; EUR 59.000 - 72.000; Tempo pieno

Descrizione del lavoro

Recordati is seeking an experienced Senior Biostatistician to provide expert methodological support across the development portfolio, ensuring robust management, analysis and interpretation of data from studies of new and marketed medicines conducted directly or through CROs. You will contribute to statistical strategy, promote contemporary methods and regulatory standards across R&D.

You will lead or supervise analyses, reviews and documentation, maintain SAS expertise, collaborate with Medical

Competenze

• Typically 10+ years of progressive biostatistics experience in pharma, biotech or CRO.
• Deep expertise in theoretical and applied statistics with regulatory expectations.
• Significant experience contributing to major regulatory submissions (NDA/MAA or equivalent).
• Strong working knowledge of GCP and CDISC standards, data integrity and reproducibility.
• Advanced SAS skills and ability to select and defend statistical methods.

Mansioni

• Collaborate with Therapeutic Area management to define robust statistical approaches.
• Provide statistical direction in cross-functional Project Teams and enable evidence-based decisions.
• Deliver high-quality statistical input to development documents and regulatory outputs.
• Lead or supervise SAP development and the production of tables, figures, listings.
• Review protocols and data management documents to maintain quality and consistency.
• Lead complex analyses and communicate implications to stakeholders.
• Maintain hands-on SAS expertise and oversee external programming partners.
• Partner with Medical and Clinical functions to interpret study data.
• Support CRO audits and pharmacovigilance data analysis; contribute to SOPs and best practices.

Conoscenze

Biostatistics expertise

Regulatory submissions experience

Clinical development knowledge

Statistics theory & methods

Communication & collaboration

Autonomy

Formazione

Advanced degree in Statistics/Biostatistics/Mathematics

PhD advantageous

Strumenti

SAS

Descrizione del lavoro

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?

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.

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.

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.

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.