Principal Biostatistician

About the role

The Principal Biostatistician will lead statistical design, analysis and interpretation of clinical trial data for drug development programs, working remotely across Europe or LATAM.

Key responsibilities

• Develop statistical analysis plans (SAPs) and ensure compliance with FDA, EMA, ICH guidelines.
• Design statistical approaches for protocols, including sample size calculations and endpoint definitions.
• Oversee interim and final data analyses and prepare statistical sections of study reports and regulatory submissions.
• Partner with clinical, regulatory, medical and data management teams to interpret results and support scientific publications.
• Mentor junior biostatisticians and contribute to strategic study planning.

Required profile

• Master's degree in Biostatistics, Statistics, Mathematics or related field (PhD preferred).
• 7‑9 years of biostatistics experience in clinical research, with 4‑6 years leading statistical design and analysis for Phase I‑IV trials.
• Experience with regulatory submissions and interactions.
• Strong communication and leadership abilities, able to manage multiple cross‑functional projects.

Required skills

• Proficiency in statistical software such as SAS and R.
• High knowledge of clinical trial design, adaptive designs, survival analysis and advanced statistical methods.