Lead Statistical Scientist Director-Biotech Trial Strategy

Premier Research Group; Verona; In loco; EUR 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Premier Research Group in Verona, Italy seeks a Statistical Scientist Director to shape statistical strategy for complex client studies and guide design through reporting.

You will translate quantitative concepts for non-statistical stakeholders, oversee innovative analysis approaches, manage deliverables, risk, and regulatory alignment, and contribute to business development across biotech, medtech, and pharma initiatives.

Competenze

• MS or PhD in statistics or closely related field; equivalent combination considered.
• 15+ years in clinical trials design and analysis, preferably in CRO.
• At least 1 year implementing innovative statistical designs in trials.
• Strong knowledge of regulatory, scientific, technical and clinical aspects of trials.
• Proficiency in SAS and R; experience with CDISC standards.
• Ability to interact with regulatory agencies (FDA, EMA, etc.).

Mansioni

• Lead statistician on complex client studies; align design, analyses, and interpretation across teams.
• Communicate quantitative concepts to non-statistical stakeholders including sponsor leadership.
• Develop sample size estimation, adaptive or Bayesian trial designs, and innovative approaches.
• Provide senior oversight for SAPs, CSRs, and regulatory documents; select deliverables.
• Identify and mitigate risks related to study design, sample size, or analysis.
• Act as project manager for biostatistics work; manage budget, scope, and timelines.
• Advise on regulatory guidelines and global submission expectations (FDA, EMA, PMDA).
• Support business development through bid defenses and capability presentations.
• Participate as independent biostatistician on DSMBs and DMCs.

Conoscenze

SAS

R

CDISC standards

Leadership

Project management

Regulatory knowledge

Biostatistics

Communication to stakeholders

Statistical modeling

Formazione

MS or PhD in statistics

equivalent combination considered

Strumenti

SAS

R

Descrizione del lavoro

Premier Research Group in Verona, Italy seeks a Statistical Scientist Director to shape statistical strategy for complex client studies and guide design through reporting.

You will translate quantitative concepts for non-statistical stakeholders, oversee innovative analysis approaches, manage deliverables, risk, and regulatory alignment, and contribute to business development across biotech, medtech, and pharma initiatives.