Principal Biostatistician

Overview

Principal Biostatistician

• Remote Europe or LATAM Be Part of One Team, One Purpose. At Emmes Group , we’re shaping the future of clinical research— where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence , we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business units— Emmes, a full-service CRO , and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies. We believe that every clinical breakthrough starts with people —people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation , ensuring that every challenge is met with perseverance and accountability. The Principal Biostatistician is a senior level expert responsible for leading the design, analysis, and interpretation of clinical trial data to support drug development programs. This role collaborates closely with cross functional teams including clinical operations, medical affairs, regulatory affairs, and data management to ensure rigorous statistical methodology and compliance with regulatory guidelines.

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 Qualifications 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. CONNECT WITH US! Find us on LinkedIn:/the-emmes-group/ Visit our website: https://www.theemmesgroup.com/ 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. CONNECT WITH US! Find us on LinkedIn:/the-emmes-group/ Visit our website: https://www.theemmesgroup.com/