QUALIFICATION SUMMARY

Ph.D. in Statistics, with 20+ years of applicable industry experience. Expertise in Biostatistics, Clinical Data Management and Statistical Programming across various therapeutic areas. Extensive proficiency of the regulatory processes internationally, commercial product development and business development.



SUMMARY OF EXPERIENCE IN THERAPEUTIC AREAS

Twenty years of experience in pre-clinical through Phase IV research. Therapeutic specialization in HIV/AIDS, Central Nervous System (anti-psychotics, anti-depressives, stroke and Alzheimer's disease), Oncology (Breast Cancer, Cervical Cancer, Leukemia, Hodgkin's Disease, Prostate, Sarcoma, Non-small Cell Lung Cancer), Infectious Diseases (Anti-Bacterial and CMV, HSV, HCV), Local Anesthetics and Analgesics, Cardiology, Urology, Rheumatoid Arthritis, Neurology, and Psoriasis.


EDUCATION

Ph.D., Statistics, University of Stockholm, Stockholm, Sweden, 1982 B.Sc., Mathematics, Statistics, Computing, University of Stockholm, 1974 L'Examen de Fran�s Commercial de la Chambre de Commerce Fran�se en Su�, Stockholm, 1974 Business economics, University of Stockholm, 1974 Baccalaureate of Science, Stockholm�s Samgymnasium, Stockholm, 1970. G.P.A.: 4.94/5.00.


EMPLOYMENT HISTORY

Vertex Pharmaceuticals Inc., Cambridge, MA 1997-2006
Vice President, Biometrics, Medicines Development Group. 2005-2006
Senior Director, Biometrics, Drug Evaluation and Approval. 2000 - 2005
Director, Biometrics, Clinical Development 1997 - 2000

Built a global strong, efficient and professional group, of currently 20 people. Implemented and validated entirely workflow, database, electronic data capture, CDISC, adaptive designs, SAS, and built a supercomputer simulation system in collaboration with Texas Tech University and SAS Institute. Responsibilities include management of Clinical Data Managers, Biostatisticians and Statistical Programmers in the entire pre-clinical, non-clinical, and clinical areas. Maintain strong interaction with senior management on program management and improvement initiatives. Chair of the Clinical Scientific Committee, �Rational Drug Development�, for the enhancement of cross-functional scientific discussions, and for the betterment of study designs and product development. Chaired the Knowledge Committee, �Knowledge Management�, for the improvement of cross-functional knowledge exchange. Project leader for implementation, validation, and training of MedDRA and dsNavigator. Chaired and coordinated eight cross-departmental improvement project teams over the entire Development Division. Chair of the EDC/CDISC Steering Committee, for the optimization of business processes through EDC and CDISC. Leading the initiative of implementing adaptive designs of clinical trials to effectivize clinical drug development. These initiatives have helped Vertex attain its strategic and innovative goals.


Amgen, Thousand Oaks, CA 1995 - 1997
Manager, Biostatistics

Built a strong, efficient and professional group of 16 people (mostly PhD statisticians). Responsibilities included management of biostatisticians in the entire preclinical and non-clinical area as well as in the clinical area of oncology for Neupogen. Frequently interacted with the FDA and investigators worldwide regarding two major BLAs.


PAREXEL International Corporation, Waltham, MA 1993 � 1995
Vice President, Biostatistics and Data Management Division 1994 - 1995
Served on a corporate level to restructure the corporation worldwide, after which the company grew 10-fold. Set long-term goals and objectives and developed performance metrics to track the progress of objectives. Supervised up to five directors and a staff of 220 people. Coordinated statistical, programming, and CDM activities, as well as lead cross-functional activities with other divisions within the company. Established and documented department standard operating procedures with continual evaluation of systems improvement. Served as a technical advisor to staff, clients, and other divisions in the company worldwide. Frequently represented clients at meetings with the FDA. Traveled frequently across the US and Europe to meet with new clients and attract new business.

Director, Biostatistics and Data Management Division 1993 - 1994
Coordinated cross-functional activities and improvements within the company. Represented the company in numerous client meetings. Establish and document department standard operating procedures with continual evaluation of systems improvement. Prepared proposals, including time estimates and general assumptions, to clients. Served as a technical advisor to staff, clients, and other divisions in the company worldwide. Frequently represent the clients at meetings with the FDA.


AstraZeneca (former Astra), Stockholm, Sweden 1982 �1993
Director, Biostatistics 1987-1993
Managed and mentored 12 biostatisticians and programmers on consulting on protocol design, data collection and management, statistical analysis and statistical reporting, reviewing reports and contributing overall to the submission of 11 NDAs. Worked as the Biostatistics liaison, transferring projects to Merck Sharp and Dohme, PA, USA. Involved in development and application of standard operating procedures within AstraZeneca worldwide. Frequently met with regulatory bodies and investigators worldwide.


Senior Biostatistician 1982 - 1987
Project biostatistician in pre- and non-clinical, toxicology, and all phases of clinical drug development; including development of study protocols, analysis plans, CRFs, data review guidelines, programming, statistical analysis and statistical reporting, reviewing reports and contributing overall to the submission of NDAs. Frequently met with regulatory bodies and investigators worldwide.


University of Stockholm, Department of Statistics 1974 - 1982
Lecturer and Professor of Statistics, Lecturing in graduate and post-graduate courses in Probability Theory, Inference Theory, Regression and Analysis of Variance, Time Series Analysis, Sampling Techniques, Dynamic Programming, Epidemiology, and Econometrics. Conducted research in the field of survival analysis.


Other Experiences
Silico Insights, Inc., Woburn, MA
Senior Scientific Advisor 1999 - 2001
Served as an advisor on scientific and business issues during the formation of an informatics company.Silico Insights' technology platform addresses the urgent needs in information processing of researchers and executives in the pharmaceutical, biotechnology and the healthcare industries.

Lecturer at Karolinska Institute, Stockholm, in medical statistics. 1974 - 1982.

Statistical advisor to members of the Nobel Prize Committee of Medicine and Physiology, 1975 - 1982.

Consulting Statistician and programmer at Roche, Hoechst, Essex, Pharmacia, The Wellcome Foundation Ltd., Karolinska Institute, Karolinska Hospital, Radiumhemmet, Huddinge Hospital, Danderyd Hospital, S� Hospital, Serafimer Hospital, Sahlgrenska Hospital, Swedish Bacteriological Laboratory, and Swedish Board for Technical Development. The Group for Applied Statistics, Stockholm, 1975 - 1982.

Lecturer at the Swedish Academy of Pharmaceutical Sciences in statistical clinical trials methodology, 1982 - 1993.

Lecturing at various research units and marketing companies within AstraZeneca in "Clinical Trials Methodology from a Statistical Point of View" (a one-week course for Clinical Research Scientists), 1983 - 1993.

Presenter at various conferences worldwide, 1976 - 2006.


TRAINING COURSES
Extensive training in leadership, software systems, therapeutic areas, and statistics (list available).


COMPUTER EXPERIENCE
Statistical Packages: SAS, S-PLUS, GLIM, BMDP, MATHEMATICA, RS/1, MINITAB,
STATXACT, LOGXACT, EAST 2000, PEST, MAPLE V, PHARSIGHT, ACSL, XPRO
Database Experience: Oracle
Programming Languages: Fortran, Cobol, Basic, RPL, JCL, SQL
Word Processing, Spreadsheets and Specialty Packages: Microsoft Word, Microsoft Excel, ClarisDraw,
Meeting Maker XP, Adobe Persuasion, Wordmark, WordPerfect, AmiPro, PowerPoint


AWARDS
1999, 2000, 2001 Professional Mentor Recognition Award, School of Public Health and Health Sciences, University of Massachusetts.


PUBLICATIONS AND PRESENTATIONS
More than 80 publications and presentations (list available).
To participate in transforming drug development to an art of the effective use of knowledge and insight, to the benefit of humanity.
To work with the goal to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments by creating new tools and methods to find answers about how the safety and effectiveness of new medical products demonstrate in faster timeframes with more certainty, at lower costs, and with better information
 
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