Senior Biostatistician Lead - Remote Europe/LATAM

Emmes; Greater London; À distance; GBP 91 000 - 136 000; Plein temps

Résumé du poste

Emmes Group is seeking a Principal Biostatistician to lead design, analysis, and interpretation of clinical trial data across drug development programs. You will collaborate with clinical operations, regulatory affairs, and data management to ensure robust statistics and regulatory compliance.

The role emphasizes mentorship of junior statisticians, staying current with industry trends, and contributing to regulatory submissions and publications. Remote Europe or LATAM work location offered.

Qualifications

• Master's degree in biostatistics or related quantitative field is required or PhD preferred.
• 7–9 years of biostatistics experience in clinical research, pharma, biotech, or CRO environments.
• 4–6 years proven experience leading statistical design and analysis for clinical trials (Phase I–IV).
• 4–6 years experience with regulatory submissions and interactions.
• Proficiency in SAS, R, or equivalent and strong knowledge of adaptive designs and survival analysis.

Responsabilités

• Lead the development of SAPs for clinical trials, ensuring proper methodology and regulatory compliance.
• Design statistical approaches for protocol development, including sample size and endpoints.
• Oversee analysis of trial data (interim and final analyses).
• Collaborate with clinical, regulatory, and medical teams to interpret results for submissions/publications.
• Provide guidance and mentorship to junior statisticians.
• Ensure statistical activities comply with FDA, EMA, ICH guidelines and SOPs.

Connaissances

Biostatistics

Clinical trial design

Statistical analysis

Regulatory submissions

Leadership

Formation

Master's Degree in Biostatistics or related field

PhD preferred

Outils

SAS

R

Description du poste

Emmes Group is seeking a Principal Biostatistician to lead design, analysis, and interpretation of clinical trial data across drug development programs. You will collaborate with clinical operations, regulatory affairs, and data management to ensure robust statistics and regulatory compliance.

The role emphasizes mentorship of junior statisticians, staying current with industry trends, and contributing to regulatory submissions and publications. Remote Europe or LATAM work location offered.