Statistical Scientist Director (Biostatistics)

TL;DR

Statistical Scientist Director (Biostatistics): Serve as lead statistician on complex key client studies for biotech, medtech, and pharma, developing statistical strategies from protocol and SAP planning through reporting with an accent on innovative trial designs, modeling approaches, and regulatory alignment. Focus on communicating complex quantitative concepts to stakeholders, identifying and mitigating study risks, and advising on global regulatory guidelines (FDA, EMA, PMDA).

Location: Italy

Company

CRO helping biotech, medtech, and specialty pharma companies bring new medicines, devices, and diagnostics to market.

What you will do

• Serve as lead statistician and point-of-contact on complex studies, leading project-level statistical strategy from protocol/SAP to reporting.
• Communicate quantitative concepts to non-statistical stakeholders including sponsors, regulators, and clinical teams.
• Develop sample size estimations, modeling, adaptive/Bayesian frameworks, and innovative trial designs.
• Provide oversight for statistical deliverables like SAPs, randomization, CSRs, publications, and regulatory documents.
• Act as project manager for biostatistics work, managing budget, scope, timeline, and risks.
• Support business development and act as independent biostatistician on DSMBs/DMCs.

Requirements

• Advanced degree (MS/PhD) in statistics or related field
• 15+ years in clinical trials design/analysis, preferably CRO; 1+ year with innovative statistical designs
• Strong regulatory, scientific, and clinical expertise in therapeutic areas
• Excellent English and Host Country (Italy) communication skills
• Advanced SAS/R programming, CDISC standards knowledge
• Willingness to travel ~20%
• Experience interacting with FDA, EMA, etc.

Culture & Benefits

• Opportunities for growth, skills development, and work-life balance.
• Your ideas and voice influence work processes.
• Flexibility to excel professionally while maintaining personal life balance.