RECENT SWOB PROJECTS
- Led Statistical Development team for analgesic drug for pharyngitis
- Led Statistical Development team for Traumatic Brain injury treatment
- Wrote Statistical Analysis Plan for new drug to treat Migraine
- Managed SAS programming for Phase III, ISS and ISE for Migraine drug NDA submission
- QA review of CRO statistical work for Phase III pain drug studies
- QA review of CRO work for medical device studies
- Phase I and II statistical design and analysis consulting to start-up Pharma companies
- Wrote SOPs and evaluated Data Management options for start-up companies
- Statistical liaison to FDA for start-up Pharma companies
- Wrote Oncology Advanced Solid Tumors Phase I Statistical Analysis Plan
- Managed all SAS programming for Phase III, ISS, and ISE for a NDA for arthritis
- Managed SAS programming and Data Management to integrate 20 trial databases for an NDA for a new dosage form for ADHD.
- Serving as the Statistician member of a Data Safety Monitoring Board for a study of an anti-malarial vaccine.
- Developed an innovative software system to more efficiently generate summary tables and listings from Clinical Trial SAS databases.