Principal Biostatistician - Global Clinical Development

Grifols; Kansas; Híbrido; USD 101.000 - 146.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Highly competitive salary

Group pension with company matching

Private medical insurance for employee

Education allowance

Wellness activities and events

Descripción de la vacante

Grifols is seeking a Biostatistician 3 to provide statistical leadership across clinical development programs. You will oversee design, analysis, interpretation, and reporting of studies, ensuring regulatory compliance and robust statistics to support submissions and publications.

You will lead collaborations with Clinical Development teams, manage CROs, and drive adherence to SOPs and regulatory standards across global health authorities.

Formación

• PhD with 8+ years in clinical development; MSc with 10+ years acceptable.
• Extensive biostatistics experience in pharmaceutical/biotech.
• Experience supporting regulatory submissions and interactions with health authorities.
• Ability to communicate complex statistical concepts to both technical and non‑technical stakeholders.

Responsabilidades

• Lead biostatistics partner to Clinical Development teams for trial design and analysis.
• Develop and review SAPs, CSRs, and statistical sections of protocols.
• Lead analysis, interpretation, and communication of trial data.
• Ensure quality and regulatory alignment of statistical deliverables.
• Oversee external biostatistics resources (CROs/consultants) and ensure timely delivery.
• Review data management and programming documentation for regulatory expectations.
• Lead blinded data review meetings and statistical oversight of studies.
• Contribute to statistical process and SOP improvements.

Conocimientos

Biostatistics expertise

Regulatory submissions

Cross-functional collaboration

Leadership

Educación

PhD in Statistics/Biostatistics

MSc in Statistics/Biostatistics

Descripción del empleo

Grifols is seeking a Biostatistician 3 to provide statistical leadership across clinical development programs. You will oversee design, analysis, interpretation, and reporting of studies, ensuring regulatory compliance and robust statistics to support submissions and publications.

You will lead collaborations with Clinical Development teams, manage CROs, and drive adherence to SOPs and regulatory standards across global health authorities.