Statistical Scientist Director: Advanced Trial Design

Premier Research Group; Terni; In loco; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Premier Research Group is seeking a Statistical Scientist Director to lead statistical strategy for complex client studies, guiding design through reporting. The role interfaces with sponsor leadership and regulatory teams, translating quantitative concepts for non-statistical stakeholders.

You will oversee innovative analyses, manage deliverables and risk, interact with regulatory agencies, and travel ~20% to support CRO projects across pharma and biotech programs in Italy and beyond.

Competenze

• MS or PhD in statistics or closely related field; equivalent combination considered.
• 15+ years’ experience in clinical trials design and analysis, preferably in CRO.
• Strong knowledge of regulatory, scientific, technical and clinical aspects of clinical trials

Mansioni

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

Conoscenze

Statistical leadership

Project management

Communication

Formazione

MS or PhD in statistics

Strumenti

SAS

R

CDISC standards

Descrizione del lavoro

Premier Research Group is seeking a Statistical Scientist Director to lead statistical strategy for complex client studies, guiding design through reporting. The role interfaces with sponsor leadership and regulatory teams, translating quantitative concepts for non-statistical stakeholders.

You will oversee innovative analyses, manage deliverables and risk, interact with regulatory agencies, and travel ~20% to support CRO projects across pharma and biotech programs in Italy and beyond.