Principal Biostatistician

PRA; Málaga; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

A leading clinical research organization seeks a Principal Biostatistician in Málaga, Spain, to lead and manage statistical responsibilities on clinical trials. This role involves developing Statistical Analysis Plans, reviewing clinical results, and contributing to scientific publications. Ideal candidates have a PhD with 5+ years of experience or a Master's degree with 10+ years of experience, coupled with deep knowledge of regulations and statistical methodologies.

Servicios

Comprehensive reward package

Competitive pay and variable incentives

Commitment to continuous learning and professional development

Formación

• 5+ years of experience in CRO or pharmaceutical companies (PhD), or 10+ years (Master's).
• Experience with Phase 2 and 3 studies.
• Strong leadership and communication skills.

Responsabilidades

• Serve as the responsible biostatistician on clinical trials.
• Develop Statistical Analysis Plans and perform senior quality review.
• Oversee outsourced trials from a Biostatistics perspective.

Conocimientos

Leadership

Communication

Proficiency in R programming

CDISC standards knowledge

Statistical analysis

Educación

PhD in statistics, biostatistics, or related field

Master's degree

Descripción del empleo

As a Principal Biostatistician, you will join the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing :

• Serve as the responsible biostatistician on clinical trials.
• Contribute to clinical study protocols.
• Develop Statistical Analysis Plans and / or perform senior quality review of statistical analysis plans.
• Review and interpret results from simple to complex clinical studies.
• Provide input in the development and review of CRFs.
• Perform lead review and QC of TFLs.
• Critically review derived datasets specifications and datasets (ADaM).
• Present key results.
• Contribute to clinical study reports.
• Review randomization specifications and schemes.
• Oversee outsourced trials from a Biostatistics perspective.
• Contribute to press releases and scientific publications.

You are :

• PhD in statistics, biostatistics, or related field with 5+ years of experience in CRO or pharmaceutical companies OR a Master’s degree with 10+ years of experience.
• Thorough knowledge of CDISC standards and regulatory requirements.
• Experience with Phase 2 and 3 studies.
• Proficiency in R programming, ESTIMANDS, adaptive designs, and writing SAPs.
• Experience in analysis creation for publications.
• Strong leadership and communication skills.
• Knowledge of ADaM and TFL programming.

Why ICON?

We offer a comprehensive reward package, including competitive pay, variable incentives, and employee benefits. We are committed to continuous learning and professional development. ICON is an equal opportunity employer dedicated to a discrimination-free workplace. If you require accommodations during the application process, please let us know. We encourage all qualified individuals to apply, regardless of whether you meet every requirement.

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