Biostatistician

About the role

A Biostatistician at Unlearn leads the integration of state-of-the-art Machine Learning (ML) approaches into the design and analysis of clinical trials. This includes tasks such as defining statistical analyses to utilize digital twins to improve the power and reduce sample size requirements of randomized controlled trials (RCTs), working with customers to optimize trial planning applications, authoring regulatory documents, presenting statistical methodology to clients, and collaborating with internal teams to develop and test methodologies.

Responsibilities

• Define statistical analyses to utilize digital twins to improve the power and lower the sample size requirements of RCTs and to provide a comparator for single arm trials.
• Carry out internal and external case studies to utilize ML-based predictions in clinical trial applications.
• Work with customers in trial planning applications to use digital twins to select and optimize inclusion/exclusion criteria, endpoints, and simulate trial outcomes.
• Author regulatory documents such as SAP and protocol sections or briefing book contributions for clinical trials that use digital twins.
• Present to clients and prospective clients on statistical methodology using digital twins and results of analyses, and represent Unlearn to the broader scientific community.
• Collaborate with internal teams to develop evidence and test methodologies.

Requirements

• At least 2 years of experience at a pharmaceutical/biotech company or CRO supporting clinical trials.
• MS or PhD in Statistics or Biostatistics.
• Experience writing statistical analysis plans and collaborating with clinical leaders.
• Strong knowledge of SAS and R.
• Experience in clinical trial design and optimization in both placebo controlled and hybrid study designs.
• Bonus points for experience with machine learning applications in clinical research, experience with regulatory interactions, and excellent external communication and interpersonal skills.

Benefits & Perks

• Generous equity participation
• 100% company-covered medical, dental, & vision insurance plans
• 401k plan with matching
• Flexible PTO plus company holidays
• Annual company-wide break December 24 through January 1
• Commuter benefits
• Paid Parental Leave

Company Culture

Unlearn is committed to building a diverse and inclusive workplace. We believe in the importance of teamwork, ambition, discipline, grit, receptiveness to new ideas, and storytelling. We are dedicated to creating lasting change in the pharmaceutical industry through responsible, rigorous, and collaborative efforts.