Principal Biostatistician (Biomarker Analyst -EMEA and US BASED)

Syneos Health

Industria de Investigación Farmacéutica

Madrid - Spanien

Manager / Gestor de equipos

Experteer Overview

As Principal Biostatistician, you will lead biomarker statistical activities across oncology studies, collaborating with cross-functional teams to design and analyze genomics- and biomarker-focused analyses. You will develop and oversee Biomarker Evaluation Plans and reports while mentoring junior statisticians and guiding regulatory submissions. The role combines hands-on analysis with leadership across projects to accelerate evidence generation for patient-centric therapies. This opportunity offers impact at scale within a global, mission-driven biopharma solutions organization.

Compensaciones / Beneficios

Total Self culture
career development and progression
peer recognition
total rewards program
supportive line management
therapeutic area training

Responsabilidades

Plan, execute and analyze biomarker and genomics statistics within clinical studies
Develop Biomarker Evaluation Plans ensuring cross-project consistency
Coordinate statistical activities for biomarker R&D and studies
Design advanced data analyses and programming for biomarker stats
Produce Biomarker Evaluation Reports with accurate interpretation
Mentor statisticians and oversee training and skill development
Prepare SAPs and collaborate with sponsors on analyses
Lead complex projects and support regulatory submissions and meetings
Provide statistical programming support and ensure data quality and documentation
Participate in DSMB/DMC activities as needed
Manage multi-project timelines, milestones and prioritization
Contribute to proposals, budgets and sponsor bid defenses
Ensure inspection readiness and regulatory compliance
Prepare for internal meetings and share ideas respectfully
Willingness to perform additional related duties
Minimal travel may be required

Requisitos principales

Strong knowledge of Biomarker evaluation, esp. Oncology and ctDNA data
Graduate degree in biostatistics or related discipline
Extensive experience in clinical trials and ability to lead multiple projects
Proficiency in programming
Deep knowledge of statistical design, analysis and regulatory guidelines (ICH)
Experience across all stages of the clinical trial lifecycle from protocol to CSR
Experience with regulatory submissions (preferred)
Excellent written and verbal communication skills
English proficiency

Excellent written and verbal communication leadership and mentoring collaboration and cross-functional teamwork Biomarker evaluation Genomics analysis ctDNA data interpretation

Descripción del puesto

As Principal Biostatistician, you will lead biomarker statistical activities across oncology studies, collaborating with cross-functional te…

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