Principal Biostatistician - Remote Europe or LATAM

About the role

Emmes Group, a full-service CRO and technology and data solutions provider, is hiring a Principal Biostatistician to lead the design, analysis and interpretation of clinical trial data for drug development programs. The role works closely with clinical operations, medical affairs, regulatory affairs and data management teams. It is open to candidates based in Europe or Latin America.

Key responsibilities

• Lead the development of statistical analysis plans (SAPs) for clinical trials, ensuring appropriate methodology and regulatory compliance.
• Design statistical approaches for protocol development, including sample size calculations and endpoint definition.
• Oversee the analysis of clinical trial data, including interim and final analyses.
• Partner with clinical, regulatory and medical teams to interpret study results and provide statistical input for regulatory submissions and publications.
• Mentor junior biostatisticians and other team members.
• Take part in study team meetings and contribute to strategic planning.
• Ensure statistical activities comply with FDA, EMA, ICH guidelines and internal SOPs.
• Prepare statistical sections of clinical study reports, regulatory documents and publications.
• Evaluate and implement new statistical methods and tools, and stay current with industry trends.

Required profile

• Master's degree in Biostatistics, Statistics, Mathematics or a related quantitative field; PhD preferred.
• 7-9 years of biostatistics experience in clinical research, preferably in pharma, biotech or CRO settings.
• 4-6 years leading statistical design and analysis for clinical trials, including Phase I-IV.
• 4-6 years of experience with regulatory submissions and interactions.
• Excellent communication and leadership skills, and ability to work in cross-functional teams and manage multiple projects.

Required skills

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