[Hiring] Principal Biostatistician @Emmes Group

Role Description

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.

• 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.
• Perform other duties as assigned.
• Comply with all policies and standards.

Qualifications

• Master's Degree in 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.

Company Description

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.

• Emmes, a full-service CRO.
• Veridix AI, our technology, data, and analytical solutions.
• We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact.
• Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.