Statistical Scientist Director

Premier Research; Spoleto; In loco; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Premier Research in Italy seeks a Statistical Scientist Director to lead biostatistics within a dynamic team. You will guide statistical strategy for pivotal studies and coordinate with sponsors and internal teams to ensure rigorous design and compliant reporting.

Ideal candidates have 15+ years in clinical trials, strong SAS/R skills, and deep regulatory knowledge for submissions to global agencies. This role requires travel and collaboration across biopharma and diagnostics projects.

Competenze

• Advanced degree in statistics or related field.
• 15+ years of clinical trials design and analysis experience, preferably in CROs.
• Experience implementing innovative statistical designs and regulatory submissions.

Mansioni

• Serve as lead statistician on complex client studies and guide statistical strategy.
• Communicate complex quantitative concepts to non-statistical stakeholders.
• Develop sample size estimation, modeling, adaptive or Bayesian approaches.
• Provide oversight for SAPs, CSRs, regulatory documents and publications.
• Identify design/analysis risks and propose mitigations.
• Act as biostatistics project manager, managing budget, scope and timelines.
• Advise on regulatory guidelines and global expectations (FDA, EMA, etc.).
• Support business development through bid defenses and sponsor relations.
• Interface as independent statistician on DSMBs/DMCs.

Conoscenze

Lead statistician

Statistical analysis

Regulatory knowledge

Communication

Project management

Travel readiness

Formazione

MS or PhD in statistics

Strumenti

SAS

R

Descrizione del lavoro

Statistical Scientist Director Premier Research Poreta, Italy

Premier Research is looking for a Statistical Scientist Director to join our Biostatistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.

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What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What You'll Be Doing:

• Serve as lead statistician on complex, key client studies, acting as point-of-contact, ensuring cohesive communication with sponsors and internal teams, and leading project-level statistical strategy from protocol/SAP planning through reporting, ensuring alignment of design, analyses, and data interpretation.
• Communicate complex quantitative concepts clearly to non-statistical stakeholders- including sponsor leadership, regulatory representatives, and clinical teams.
• Develop sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs.
• Develop or provide senior oversight for statistical deliverables, including: statistical selection of protocols, statistical Analysis Plans (SAPs), randomization specifications and statistical contributions to CSRs, publications, and regulatory documents.
• Identify risks related to study design, sample size, or analysis approaches and proactively propose mitigation strategies.
• Act as project manager for biostatistics stand-alone work and drive high-quality statistical deliverables while managing budget, scope, and timeline expectations.
• Advise clients on regulatory guidelines, statistical principles for submissions, and global expectations (FDA, EMA, PMDA, etc.).
• Support business development through participation in bid defenses, capabilities presentations, RFP strategy and build trusted scientific relationships with sponsors and influence decision-making through evidence-based recommendations.
• Act as an independent biostatistician on DSMBs and DMCs.

What We Are Searching For:

• Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field.
• Equivalent combination of education, training and experience will be considered.
• 15+ years' experience in clinical trials design and analysis, preferably in a CRO environment.
• At least 1 yr technical experience in clinical trials design and analysis implementing innovative statistical analysis.
• Previous experience implementing innovative statistical designs.
• Strong knowledge of regulatory, scientific, technical and clinical expertise in conduct of clinical trials in the respective area of focus as demonstrated by past positions related to the therapeutic area in the CRO and Pharma/Biotech sector.
• Strong computer skills, with knowledge of advanced programming skills with standard software, including SAS, R.
• Excellent working knowledge of CDISC standards and application of these standards to projects.
• xysqume Ability to manage and de-escalate difficult situations with clients, teams, and management.
• Demonstrated experience in interacting with regulatory agencies (e.g., FDA, EMA, EU member states).
• Excellent English and Host Country Communication skills (verbal, written & interpersonal).
• Excellent organizational and time-management skills, able to prioritize work to handle multiple tasks and meet deadlines in a dynamic environment.
• A willingness to travel, ~20%.

Location: Italy

Type: Full time