Senior Director, Biostatistics

Premier Research; Málaga; Presencial; EUR 120.000 - 190.000; Jornada completa

Descripción de la vacante

Premier Research is seeking a Senior Director of Biostatistics to lead a high-performing team in Málaga, Spain. You will shape strategic statistical initiatives and oversee delivery across clinical trials and related projects.

The role requires extensive leadership, expert SAS programming, and deep knowledge of CDISC standards, with a track record in regulatory interactions and biostatistics leadership.

Formación

• Advanced degree (MS or PhD) in statistics or closely related field.
• 12+ years of experience in clinical trials design and analysis.
• 7+ years of experience as supervisor/manager.
• Excellent knowledge of clinical trial design and analysis principles.
• Excellent knowledge of CDISC standards and their application.
• Strong statistical theory and methods knowledge.
• Experience interacting with regulatory agencies (FDA/EMA).
• Ability to lead and motivate a diverse team.

Responsabilidades

• Manage and de-escalate difficult situations with clients, teams, and management.
• Demonstrated critical thinking with strategic initiatives.
• Coach and mentor others.
• Lead process improvement efforts.
• Maintain awareness of biostatistics developments through literature and training.
• Align operations between Biostatistics and other departments for productivity.
• Provide oversight and reporting of project progress and financial health.
• Develop and implement strategies to achieve goals.
• Oversee staffing and operational aspects of the Biostatistics group.
• Consult sponsors on statistical issues.
• Peer-review draft analysis plans and provide feedback.
• Support business development through bid defenses and capability presentations.

Conocimientos

Leadership

SAS programming

CDISC knowledge

Clinical trial design

Statistical analysis

Regulatory experience

Mentoring

Project oversight

Communication

Business development support

Educación

MS or PhD in Statistics or closely related field

Herramientas

SAS

CDISC standards

Descripción del empleo

Premier Research is looking for a Senior Director, Biostatistics 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.

• 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:

• Ability to manage and de-escalate difficult situations with clients, teams, and management




• Demonstrated critical thinking with a history of bringing forward strategic initiatives




• Capability and willingness to coach and mentor others




• Ability to lead process improvement efforts




• Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.




• Integrates operations between Biostatistics and other departments to obtain increased productivity, efficiency and quality




• Provides oversight and reporting of project progress and financial health within Biostatistics




• Develops and implements strategies to actualize goals




• Strategic responsibility for all staffing and operational aspects of the allocated Biostatistics group




• Provides consultancy to sponsors on statistical issues




• Peer reviews draft statistical analysis plans and provides feedback




• 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.

What we’re looking 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.




• 12+years’ experience in clinical trials design and analysis




• 7+years’ experience as supervisor/manager




• Excellent demonstrated working knowledge of basic clinical trial design and analysis principles.




• Excellent working knowledge of CDISC standards and application of these standards to projects.




• Excellent working knowledge and understanding of advanced statistical concepts




• Strong computer skills, with evidence of advanced SAS programming skills especially statistical inferential procedures




• Demonstrated experience in interacting with regulatory agencies (e.g.FDA, EMA, EU member states)




• Ability to motivate and lead a team of varying levels of status and ability

Specific experience in Rare Disease/Specialty is highly desirable