Accomplishments

·         Manager of Statistics and Clinical Data Management for an International CRO

·         7 years recent SAS programming and CDM, recently at CRO and Pharmas

·         Statistical programmer analyst support for 6 clinical trials at Medtronic, 5 at Baxter

·         Identified errors causing corrupted extracts from a large clinical database holding pharmaceutical data, and was the key player in the resolution.

·         Used Bayesian Analysis to create genetic diagnostic criteria now used in UK

·         Trained and supervised nurses extracting and coding information from patient notes. 

·         Designed, programmed, documented e-CRFs.  Trained and supervised on data collection and management protocols.

·         Analyzed patient data for an NHS service development study; provided input into research direction, publication, and patient management.

·         Specified and directed the development of a clinical patient management system for UK Lipid Clinics (http://www.londonideas.org/internet/FHCascade/fhfamilydb.htm)

 Experience

 Entrepreneur, Shanghai Nov-2009 to Present

For the past 4 months, I’ve been in Shanghai.  I was a partner in a Biostats company (FBS Data Services), where I helped do business development, wrote SOPs, installed an EDC system (OpenClinica) and updated version 3.0 it so it could work in Chinese as well as English, interviewed potential hires, created brochures and other marketing materials and worked on a SAS language macro library.  However, the data services company has negative cash flow, and I have decided to look for other employment.

Baxter BioSciences, Vienna, Austria, March-2008 to Nov-2009

Senior Statistical Programmer, SAS (Macro, Base, Stats, Graph, ODS, SQL), CDISC

·         Statistical Analysis and Reporting of Global Clinical Trial Data and Results

·         Requirements Analysis, Design, Development, Testing, Validation, Documentation

·         Macros Libraries.  Tables, Figures and Listings.

·         CDISC specification and programming, SDTM and ADaMs

·         Simultaneously work on many studies, programming and validation, different indications

KendleWits Medical Consulting Co., Ltd., Shanghai, China, Oct-2006-Feb-2008

Manager BioStats & DM: SAS (as above), SOPs, Training, SAPs, BD

·         Statistical Analysis and Reporting of Client Clinical Trial Data and Results

·         Requirements Analysis, Design, Development, Testing, Validation, Documentation

·         SOPs (program and macro creation, validation and version control)

·         SAPs, Programming Specs, Mockups Macros Libraries.  Tables, Figures and Listings.

·         Recruit, Supervise and Train Junior Staff—Programmers and Statisticians

·         Primary Contact and Lead Programmer for Major Clients

·         Promotional Materials, Trade Show Booth, Negotiate/Supervise Vendors and Office Space

Medtronic CRDM Clinical, Shoreview, MN, Jan-2006-Oct-2006

Senior Clinical Programmer Analyst:  SAS

·         Statistical Analysis and Reporting of Clinical Trial Data and Results

·         Requirements Analysis, Design, Development, Testing, Validation, Documentation

·         Developed: Macros Libraries, Tables, Figures and Listings.

·         Simultaneously Served on: 4 study teams, 2 publication committees

·         6 pre and post-market clinical trials: Each >10,000 patients, >1,000,000 data records

·         Mentoring and Leadership: Head of the biweekly statistical programmer’s forum

·         Medtronic Training: Pharmacology, Cardiovascular, Anatomy, ECGs

·         Exceptional Contributions: Stepped In and Solved Complex Problems in a Critical Study

·         Patent Suggestions: Vector Matching to Diagnose Arrhythmia within the Device