Senior Biostatistician: Lead Statistical Strategy & Impact

Recordati; Milano; Hybrid; EUR 59,000 - 72,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Biostatistics expertise

Regulatory submissions experience

Clinical development knowledge

Statistics theory & methods

Communication & collaboration

Autonomy

Education

Advanced degree in Statistics/Biostatistics/Mathematics

PhD advantageous

Tools

SAS

Job description

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