BIOSTATISTICIANBolognese

PERSONAL PROFILE

  • 40 years in life sciences as a biostatistician

EXPERTISE

Biostatistician; Statistical Analysis; Clinical Development Program and Trial Design; Adaptive Designs and Implementation; Statistical Support of Biomarker Development; Technical Oversight/Guidance of Statistical Analysis Vendors; Software Design, Development, Testing, and Refinement. Authored nearly 100 peer-reviewed publications and articles and made numerous presentations.

PROFESSIONAL EXPERIENCE

Senior Director, Strategic Consulting / Clinical Trial Services, Cytel, Inc.

Assist pharmaceutical and biotech clients with design of clinical development programs and clinical trials, including adaptive designs and implementation. Provide statistical/technical guidance and oversight of out-sourced services for statistical analysis and reporting of clinical pharmacology studies. Research adaptive dose-finding clinical trial designs. Participate in software design, development, testing, and refinement.

Senior Director, Scientific Staff, Merck & Co., Inc.

Coordinated statistical support of all experimental medicine studies, working with statisticians in clinical pharmacology and therapeutic areas to ensure consistency of, and enhance, statistics support for experimental medicine, proof-of-concept study design, and biomarker development. Led collaborative research and software development effort with Cytel, Inc. to develop dose-adaptive study design software for various designs including random walk, Bayesian D-optimal, CRM, NDLM, etc. and perform simulations to compare those designs for both continuous and binary endpoints. Supervised 6 statisticians working on anti-inflammatory drug development projects, including 3 coxibs and 2 other drugs with new mechanisms. Led inter-departmental group to design, build, test, and implement a new clinical allocation schedule system to support all clinical trials. Coordinated all aspects of statistical support to MK-0966 (VIOXXTM), COX-2-specific inhibitor, and Phase 3 program of studies for three major claims (osteoarthritis, acute analgesia, GI safety), culminating in successful completion, filing and approval in over 70 countries worldwide, including the US and EU. Continued responsibility for VIOXXTM Phase 5 filings of rheumatoid arthritis, low back pain, spontaneous adenomatous polyposis, and cardiovascular safety claims. Management review responsibility for MK-0663 (ARCOXIATM), COX-2-specific inhibitor, Phase 3 filing in 2001, and re-filing in the US in 2003 (claims include osteoarthritis, rheumatoid arthritis, acute analgesia, low back pain, gout, ankylosing spondylitis, GI safety), and for all Rahway Clinical Pharmacology statistics support until 2002. Responsible for statistical design of 3 outcomes (“mega-”) trials: cardiovascular thrombotic serious AEs for VIOXXTM and ARCOXIATM and adenomatous colon polyps for VIOXXTM. Provided technical user input into the design, testing, and implementation of a new computerized information processing system for clinical drug development (CRISP).

Associate Director, Biometrics Research, Merck & Co., Inc.
Responsible for statistical support to all on-site non-clinical research projects, including supervision. Delivered experimental design, data analysis, development of statistical methodology for specific applications, development and administration of statistical training programs, and development and/or validation of statistical computer software for research applications. Supported tissue residue studies for animal health products and agricultural product development studies. Involved in co-developing model to predict performance of extended release formulation of ivermectin based on 2 months of data and associated quality control release test.

Associate Director, Clinical Pharmacology Biostatistics, Merck & Co., Inc.
Oversaw all statistical aspects of Clinical Pharmacology International Research. Participated in cardiovascular/ renal and anti-inflammatory/analgesic projects. Reviewed and approved all protocols for clinical pharmacologic trials. Involved in design, analysis, and statistical report writing for Clinical Pharmacology and Phase 2 trials for NDAs and international regulatory submissions. Performed statistical programming and development.