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 / Beneficios versátil 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 (Bilbao)
🏢 Premier Research
📍 Bilbao