Statistical Scientist Director

TL;DR

Statistical Scientist Director: Lead biostatistics on complex clinical trials, owning statistical strategy from protocol/SAP planning through reporting with an accent on adaptive or Bayesian frameworks, sample size estimation, and regulatory-ready statistical deliverables. Focus on communicating quantitative concepts to non-statistical stakeholders, managing study risks, and advising on global regulatory expectations across FDA, EMA, and other agencies.

Location: Spain

Company

hirify.global supports biotech, medtech, and specialty pharma companies in turning breakthrough science into new medicines, devices, and diagnostics.

What you will do

• Serve as lead statistician and point-of-contact on key client studies, driving cohesive communication between sponsors and internal teams.
• Lead project-level statistical strategy from protocol/SAP planning through reporting, ensuring alignment of design, analyses, and data interpretation.
• Develop sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs.
• Provide senior oversight for statistical deliverables, including protocol statistical selection, SAPs, randomization specifications, and statistical contributions to CSRs, publications, and regulatory documents.
• Identify study design, sample size, and analysis risks and propose mitigation strategies.
• Act as project manager for biostatistics stand-alone work, managing budget, scope, and timeline expectations; advise on regulatory guidelines and statistical principles for submissions.

Requirements

• MS or PhD in statistics or a closely related field (or equivalent education, training, and experience).
• 15+ years of experience in clinical trials design and analysis, preferably in a CRO environment.
• At least 1 year of technical experience implementing innovative statistical analysis in clinical trials design and analysis.
• Strong knowledge of regulatory, scientific, technical, and clinical aspects of clinical trial conduct in the relevant therapeutic area.
• Advanced programming skills with SAS and R; strong working knowledge of CDISC standards and their application.
• Excellent English and host-country communication skills (verbal, written, interpersonal); ability to interact with regulatory agencies (e.g., FDA, EMA, EU member states) and manage/de-escalate difficult situations.

Culture & Benefits

• Opportunity to influence how work is done and contribute ideas to team practices.
• Focus on growth, skills development, and work-life balance with flexibility.
• Travel expectation of about 20%.
• Work centered on delivering medical innovation that improves patient outcomes.

Hiring process

• Interviews to assess biostatistics leadership, regulatory experience, and ability to communicate complex quantitative concepts.
• Evaluation of experience with innovative trial designs, statistical deliverables, and client/stakeholder management.