Linda Collins is a member of the team that launched PharmaStat in 2005. She has more than 25 years of programming experience in clinical and pharmaceutical applications.
She began working in the biotechnology industry in 1988, after five years of managing clinical databases and instrumental data capture at the University of California San Francisco Medical Center. Since 1988, she has performed analyses of clinical trials for over 25 sponsors, including integrated analyses of up to 60 studies. More recently, she has become an active participant in the development of the CDISC ADaM standard.
Linda has made use of this experience to design efficient and reliable processes and tools for analysis. She is the principal designer of the Analysis Programming Tools (APT©) Library, an SAS©-based analysis toolkit. She has also developed SAS©-based systems for integrating analysis with documentation and quality control. The software developed under her direction is used in-house at PharmaStat, and by a number of leading biopharmaceutical companies.
Areas of expertise for Linda Collins:
- CDISC ADaM standards
- Clinical study analysis and reporting
- Data warehousing and integrated safety reporting
- Electronic submission preparation
- Procedures, technology and standards for biostatistical analysis
- Software validation, documentation and training