Unlearn is advancing AI to eliminate trial and error in medicine by producing AI-generated digital twins of individual trial participants, enabling smaller and more efficient clinical trials to bring effective medicines to patients sooner.
Requirements
- Strong knowledge of SAS and R.
- Experience in clinical trial design and optimization in both placebo controlled and hybrid study designs.
- Experience with machine learning applications in clinical research.
- Experience writing statistical analysis plans and collaborating with clinical leaders.
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.
Other
- At least 2 years of experience at a pharmaceutical/biotech company or CRO supporting clinical trials.
- MS or PhD in Statistics or Biostatistics.
- Experience with regulatory interactions.
- Excellent external communication and interpersonal skills.