Statistical Scientist Director - Trials Leader

Premier Research Group; Varese; In loco; EUR 140.000 - 200.000; Tempo pieno

Descrizione del lavoro

Premier Research Group is seeking a Statistical Scientist Director to lead statistical strategy, design and analysis across biotech, medtech and pharma initiatives in Italy.

You will translate quantitative concepts for non-statistical stakeholders, oversee innovative analysis approaches, and manage risk, scope, and timelines while supporting business development and client relationships.

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.
• Proficiency with SAS and R; experience with CDISC standards.
• Excellent English and host country communication skills; willingness to travel ~20%.

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 sponsor relationships.

Conoscenze

SAS

R

CDISC

Leadership

Project management

Communication

Biostatistics

Regulatory knowledge

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, design and analysis across biotech, medtech and pharma initiatives in Italy.

You will translate quantitative concepts for non-statistical stakeholders, oversee innovative analysis approaches, and manage risk, scope, and timelines while supporting business development and client relationships.