Senior Statistician (Biopharmaceutical)

TL;DR

Senior Statistician (Biopharmaceutical): Providing statistical expertise for clinical trials from design to reporting with an accent on regulatory compliance and study delivery. Focus on sample size calculations, Statistical Analysis Plans (SAP), and ensuring CDISC standards are properly implemented.

Location: Parma, Italy (remote working available)

Company

International research-focused biopharmaceutical group with 90 years of experience, operating in more than 30 countries.

What you will do

• Provide statistical expertise for clinical trials from design through execution and reporting.
• Develop Study Protocols, sample size calculations, and Statistical Analysis Plans (SAP).
• Collaborate with Clinical Development Plan (CDP) teams to align study characteristics.
• Manage external providers, prepare RFPs, and monitor performance.
• Review analysis datasets and metadata to ensure CDISC standards are properly implemented.
• Prepare executive summaries, results presentations, and publications including abstracts and posters.

Requirements

• PhD or MSc degree in Statistics.
• Significant experience in statistics for clinical trials within pharmaceutical companies or CROs.
• Strong knowledge of drug development processes and regulatory requirements.
• Proficiency in SAS, R, and tools for sample size calculation.
• Expertise in international data collection standards (CDISC).
• English: Fluent (C1).

Culture & Benefits

• Comprehensive healthcare programs.
• Work-life balance initiatives.
• Robust relocation support.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.