Director, Statistical Science for Clinical Trials

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

Descrizione del lavoro

Premier Research Group in Bari, Puglia, Italy, seeks a Statistical Scientist Director to lead statistical strategy for complex client studies, guiding design through reporting. You will translate quantitative concepts for non-statistical stakeholders and oversee innovative analysis approaches.

You will manage deliverables, risk mitigation, and regulatory alignment while supporting business development and client relationships across biotech, medtech, and pharma initiatives.

Competenze

• 15+ years of experience in clinical trials design and analysis.
• At least 1 year of experience implementing innovative statistical designs in trials.
• Strong knowledge of regulatory, scientific, technical and clinical aspects of clinical trials.

Mansioni

• Serve as lead statistician on complex client studies, acting as point-of-contact and 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
• MS or PhD in statistics or closely related field; equivalent combination considered
• 15+ years’ experience in clinical trials design and analysis, preferably in CRO
• At least 1 year of experience in implementing innovative statistical designs in trials
• Strong knowledge of regulatory, scientific, technical and clinical aspects of clinical trials in relevant therapeutic areas
• Proficiency in SAS and R; experience with CDISC standards
• Ability to interact with regulatory agencies (FDA, EMA, etc.)
• Excellent English and host country communication skills; strong organizational and time-management abilities
• Willingness to travel (~20%)
• excellent communication and presentation skills
• leadership and team coordination
• ability to manage difficult client situations
• SAS
• R
• CDISC standards

Conoscenze

Leadership

Communication

Time management

Client management

Formazione

MS or PhD in statistics

Strumenti

SAS

R

CDISC standards

Descrizione del lavoro

Premier Research Group in Bari, Puglia, Italy, seeks a Statistical Scientist Director to lead statistical strategy for complex client studies, guiding design through reporting. You will translate quantitative concepts for non-statistical stakeholders and oversee innovative analysis approaches.

You will manage deliverables, risk mitigation, and regulatory alignment while supporting business development and client relationships across biotech, medtech, and pharma initiatives.