Major accomplishments of SWOB:
— Complete responsibility for SAS programming to integrate 20
clinical trial databases into an ISS for an NDA for a
New dosage form (patch) for the treatment of ADHD
— Primary statistical consultant to several startup
Pharmaceutical companies. Advised on Design and
Analysis of studies. Wrote SOPs. Evaluated Technology.
Wrote Data Management and Data Analysis plans.
Statistical Liason to FDA.
— Performed Quality Assurance review of Statistical Methods,
Results, and SAS programming performed by CROs.
— Managed SAS programming for 2 pivotal Phase III studies
For an NDA for a new treatment for arthritis, and integrated
5 study databases for the ISS and ISE.
— Extensive experience in Patient Reported Outcomes (PRO)
endpoints, particularly “Pain” related clinical trials (e.g.
Migraine, heartburn, sore throat, dental pain, cancer pain, etc.)