Kathy Boussina joined PharmaStat in 2012, bringing with her more than 20 years of statistical computing experience in the biotech and pharmaceutical fields.
Her experience spans small, mid and large companies, with positions in management, infrastructure building, regulatory submissions and SAS programming. Her projects have ranged from Investigational New Drug (IND) application through NDA submissions (ISS, ISEs, CSRs, SDTM and ADaM preparation). Disease indications include oncology, cardio-pulmonary and infectious diseases.
Kathy has held statistical computing leadership positions in a number of companies, including Onyx Pharmaceuticals, Genentech Inc., Pharmacyclics Inc., and ALZA Corporation. She represents PharmaStat in the San Francisco Bay area.
Areas of expertise for Kathy Boussina:
- Clinical data analysis/SAS programming and data management
- Regulatory submissions
- Infrastructure and SOP development
- CDISC/ADaM development and legacy conversion