Lisa Ensign

About Lisa Ensign

I am passionate about pursuing projects to improve the safety and efficacy of clinical…

Experience

1. Vice President, Statistical Innovation Group

   Medidata Solutions

   Jan 2022 — Present

   I am passionate about pursuing projects to improve the safety and efficacy of clinical trials. My work in the Integrated Evidence Statistical Innovation Group is focused on creating analytical approaches to improve the efficiency and rigor of clinical trials, centered on the use of external controls. I received a MS in biostatistics from Harvard University and a PhD in clinical science from the University of Colorado, where I am also an instructor on ethics and the responsible conduct of research. Specialties: biostatistics, control arms, synthetic control arms, FDA/ICH regulations, oncology, drug and medical device clinical trials, propensity score methods, machine learning, postmarket surveillance natural language processing/NLP, risked based monitoring, risked based quality management, software system development, CRF/eCRF design/system validation.

Skills

• Quality Assurance
• Life Sciences
• Biostatistics
• U.s. Food and Drug Administration (Fda)
• Lifesciences
• Business Process Improvement
• Statistics
• Pharmaceutical Industry
• Pharmacovigilance
• Machine Learning
• Clinical Research
• CRO
• Nlp
• Text Mining
• Capa
• Quality System
• Protocol
• Validation
• Maude Database
• Clinical Trials
• Medical Devices
• Healthcare
• U.s. Title 21 Cfr Part 11 Regulation
• Project Management
• 21 Cfr Part 11
• Clinical Data Management
• Fda
• CRO Management
• Process Improvement
• Data Management