Want to know if this job is worth applying to?
Italia
Remote only
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. 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.
Develops sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs.
Develops or provides 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.
Acts 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.
Acts 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.
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%