Principal Biostatistician

Overview

Principal Biostatistician - Remote Europe or LATAM

Responsibilities

• Lead the development of statistical analysis plans (SAPs) for clinical trials, ensuring appropriate methodology and adherence to regulatory standards.
• 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 scientific publications.
• Provide guidance and mentorship to junior biostatisticians and other team members.
• Participate in study team meetings and contribute to strategic planning.
• Ensure all statistical activities comply with FDA, EMA, ICH guidelines, and internal SOPs.
• Prepare statistical sections of clinical study reports, regulatory documents, and publications.
• Support interactions with regulatory agencies regarding statistical issues.
• Evaluate and implement new statistical methods and tools to enhance analysis efficiency and quality.
• Stay current with industry trends, regulatory guidance, and advances in biostatistics.
• Performs other duties as assigned
• Complies with all policies and standards
• Master's Degree Biostatistics, Statistics, Mathematics, or a related quantitative field. Required or

PhD Preferred

• 7-9 years of biostatistics experience in clinical research, preferably within pharma, biotech, or CRO environments. Required
• 4-6 years Proven experience leading statistical design and analysis for clinical trials, including Phase I IV. Required
• 4-6 years Experience with regulatory submissions and interactions. Required
• Proficiency in statistical software such as SAS, R, or equivalent. High
• Strong knowledge of clinical trial design, adaptive designs, survival analysis, and other advanced methods. High
• Excellent communication and leadership skills. High
• Ability to work collaboratively in cross functional teams and manage multiple projects simultaneously. High
• If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.