Overview

As Statistical Scientist Director, you will lead statistical strategy for key client studies, acting as primary liaison among sponsors and internal teams. You will shape design, analyses, and interpretation, and oversee statistical deliverables from protocol planning to reporting. You’ll translate complex quantitative concepts for non-statistical stakeholders and contribute to regulatory documents and publications. This role blends leadership, innovative design, and cross-functional collaboration to advance medical innovation. You will guide teams, mentor colleagues, and drive high-impact outcomes for patients and sponsors.

Compensaciones / Ventajas

- flexible work arrangements
- growth opportunities and mentorship
- balance with life requirements
- opportunity to contribute to life-saving therapies
- travel opportunities (~20%)
- collaborative, impact-driven culture

Responsabilidades

- Lead statistician on complex client studies and drive project-level statistical strategy from protocol/SAP planning through reporting
- Communicate quantitative concepts clearly to non-statistical stakeholders including sponsor leadership and regulatory representatives
- Provide statistical input to Clinical Trial Reports and Protocols
- Develop sample size, modeling approaches, adaptive or Bayesian trial designs
- Oversee preparation of SAPs, randomization specifications, and statistical contributions to CSRs and regulatory documents
- Collaborate with statistical programmers to ensure correct method implementation and interpretation




- Independently develop SAS/R programs as needed
- Identify design/analysis risks and propose mitigation strategies
- Act as project manager for biostatistics work, managing budget, scope, and timelines
- Ensure cross-project statistical consistency and contribute to portfolio-level strategy
- Advise on regulatory guidelines and global expectations for submissions
- Support business development through bid defenses and capabilities presentations
- Provide internal consultancy on statistical issues and champion innovative methodologies
- Mentor team members and support departmental training and SOPs
- Act as biostatistician on DSMBs/DMCs
- Perform other duties as assigned

Requisitos principales

- 15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment
- 1+ year of technical experience in innovative statistical designs in trials
- Strong knowledge of regulatory, scientific, technical and clinical aspects in clinical trials within relevant therapeutic areas
- Strong programming skills in SAS and R
- Excellent working knowledge of CDISC standards and application
- Ability to communicate statistical concepts to scientists and non-scientists
- Experience interacting with regulatory agencies (FDA, EMA, etc.)
- Proven ability to manage difficult stakeholder situations and ethical, data-driven decision making
- Excellent English and host country communication skills
- Willingness to travel (~20%)

- clear communication
- leadership and mentoring
- stakeholder management
- SAS
- R
- CDISC standards

📌 Statistical Scientist Director (Madrid)
🏢 Premier Research
📍 Madrid