Biostatistician for Pharmaceutical Data Analysis and Clinical Trial Support

Technical Consultant #1169

2002 - Present Independent Consultant

Statistical services to the pharmaceutical, biotech, and medical device industries and the National Institute of Health (NIH).
Statistical services in the development of clinical development plans, clinic trial protocols, statistical analysis plans, and clinical trial reports; and in the NDA submissions.
Represent companies when meetings with the FDA and advisory committee meetings for NDAs.
Provide statistical support to the data and Safety Monitory Board (DSMB) for clinical trials.
Perform sensitivity and exploratory analysis for the investigation of efficacy characteristics, scientific publications, and responses to the FDA.
Provide SAS programming support in data processing and statistical analyzes.
Develop applications for computer-aided data review, clinical data entry, data validation, and statistical analysis, etc.

2000 - 2002 Associate Director, Biostatistics,ViroPharma Inc., Exton, PA

Provided statistical support in the development of clinical development plans, clinical trial protocols, statistical analysis plans, and clinical trial reports in the treatment of meningitis and viral respiratory infection (common cold).
Performed numerous exploratory analyses to identify clinically relevant and statistically robust efficacy endpoints.
Prepared for the responses to the FDA, mock-panel meetings, rehearsal meetings, and the final FDA advisory committee meeting for a NDA.

1996 - 2000 Various Positions, AstraZeneca Inc., Wilmington, DE

Biometric Product Team Leader in Pain Control Therapeutic Area
Member of the Protocol Review Committee to review and approve clinical trial protocols.
Statistical support in clinical development plans for multiple compounds in the Pain Control Therapeutic Area.
Skills Development Adviser (Manager), SAS Programming Group
Member of the Protocol Review Committee.
Statistical and Programming Team Leader, Clinical Pharmacology and Exploratory Group
Member of the Protocol Review Committee.
Lead a team of three statisticians and three SAS programmers working on clinical pharmacology and exploratory clinical studies.
Global Project Statistician for two pain relief compounds; suggested development of clinical operating plans for Phase I, II, and III trials, and target claims statements of the compounds.

1991 - 1996 Senior Biostatistician, ClinTrials Research Inc., Lexington, KY

1989 - 1991 Teaching Assistant, University of Kentucky,