Statistical Scientist Director

Premier Research; España; Presencial; EUR 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexibility in work-life balance

Opportunities for personal growth

Impact on meaningful patient outcomes

Descripción de la vacante

A global research organization in Spain is seeking a Statistical Scientist Director to lead key client studies in clinical trials. This role demands extensive experience in statistical analysis, innovative trial design, and strong programming skills in SAS and R. The ideal candidate will have an advanced degree in statistics, along with over 15 years of relevant experience and a solid understanding of regulatory standards. Join us to help deliver vital medical innovations and mentor upcoming talent in the industry.

Formación

• 15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment.
• Technical experience in clinical trials design and analysis implementing innovative statistical analysis.
• Strong knowledge of regulatory standards and application in clinical trials.

Responsabilidades

• Serve as lead statistician on complex, key client studies.
• Communicate complex quantitative concepts clearly to stakeholders.
• Provide statistical input to Clinical Trial Reports and Protocols.
• Develop sample size estimation and innovative trial designs.

Conocimientos

Statistical analysis

Clinical trials design

SAS programming

R programming

Regulatory knowledge

Communication skills

Project management

Educación

Advanced degree (MS or PhD) in statistics or closely related field

Herramientas

SAS

R

Descripción del empleo

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. 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.

Join us and build your future here.

• 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.

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.
• Provide statistical input to Clinical Trial Reports and Clinical Trial Protocols.
• Develop 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
  • Statistical contributions to CSRs, publications, and regulatory documents
• Collaborate closely with statistical programmers to ensure proper implementation of methods and accurate interpretation of outputs.
• Independently develop SAS/R programs as needed.
• 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.
• Oversee cross-project statistical consistency, supporting portfolio-level scientific strategy when applicable.
• 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.
• Provides internal consultancy to team members (internal/external to Biostatistics) on statistical issues, acting as an SME for multiple statistical topics and championing innovative methodologies such as adaptive designs, Bayesian methods, and predictive modeling.
• Keeps up with new and upcoming statistical techniques as well as regulatory authority developments, mentors and trains department members, and support the development and maintenance of departmental training, SOPs and guidelines.
• Acts as an independent biostatistician on DSMBs and DMCs.
• Perform other work-related duties as assigned

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 communicate basic statistical concepts to other scientists and nonscientists.
• 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).
• Demonstrated critical thinking with a history of bringing forward strategic initiatives.
• 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%.