Principal Biostatistician

PRA; España; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

Join a leading clinical research organization as a Principal Biostatistician, where you will play a crucial role in clinical trials and contribute to scientific publications. This position offers the opportunity to lead statistical analysis efforts, develop protocols, and ensure compliance with regulatory standards. You will work in a collaborative environment, leveraging your expertise in biostatistics to drive impactful results. If you are passionate about advancing healthcare through data-driven insights, this role is perfect for you.

Servicios

Competitive pay

Variable incentives

Employee benefits

Continuous learning opportunities

Formación

• PhD or Master's degree with extensive experience in CRO or pharmaceutical companies.
• Thorough knowledge of CDISC standards and regulatory requirements.

Responsabilidades

• Serve as the responsible biostatistician on clinical trials.
• Develop Statistical Analysis Plans and perform quality review.

Conocimientos

R programming

Leadership

Communication Skills

Knowledge of CDISC standards

Statistical Analysis Plans (SAPs)

ADaM and TFL programming

Educación

PhD in Statistics or Biostatistics

Master's Degree in related field

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.