Senior Biostatistician — Clinical Research & AI Validation

About Simulation95

Simulation95 is building at the intersection of artificial intelligence, healthcare, and life sciences. We believe meaningful progress starts with people who understand the hardest problems firsthand. We’re bringing together experts, researchers, and builders to turn that understanding into technology that matters.

For curious people who take their craft seriously, this is an opportunity to help shape something early—with challenging problems, meaningful responsibility, and room to make a lasting contribution.

About the role

You will help develop and validate AI applications for clinical research, drawing on your experience in study design, statistical analysis, and drug development. Working with technical teams and industry experts, you will assess whether the tools produce accurate, reproducible analyses and defensible conclusions.

We are looking for a biostatistician with substantial experience in a pharmaceutical company, biotechnology company, or contract research organization (CRO). Established relationships across the industry will also help you identify practical research needs and bring relevant experts into the work.

Responsibilities

• Translate clinical research needs into requirements for AI applications and analytical tools.
• Review and validate AI-generated statistical analyses, code, study designs, and conclusions.
• Define standards for accuracy, reproducibility, and appropriate human review.
• Assess endpoints, sample sizes, statistical analysis plans, and the interpretation of clinical evidence.
• Work with technical teams to identify errors and improve application performance.
• Identify industry needs, engage expert collaborators, and help develop research partnerships.

Qualifications

• Extensive biostatistics experience, including direct responsibility for clinical trial design, analysis, and reporting.
• Established relationships with clinical development, biostatistics, or research teams in pharma, biotech, or CROs.
• Strong proficiency in R or SAS and the ability to explain complex statistical decisions clearly.
• Advanced degree in biostatistics, statistics, or a related quantitative field.

Preferred experience

• Evaluation of AI tools or validation of analytical software.
• Clinical research in oncology or rare diseases.