In Consulting Services

PharmaNet offers a comprehensive range of early- and late-phase consulting services on topics including: international regulatory affairs; scientific and medical affairs; quality; risk management; chemistry, manufacturing and controls; as well as biopharmaceutical investor issues.

Biography

Mary F. Johnson, PhD

Executive Vice President, Biostatistics
504 Carnegie Center
Princeton, NJ 08540
USA

Tel: 609 951 6800
Fax: 609 720 5006
E-mail: mjohnson@pharmanet.com

Expertise: Biostatistics, protocol development, statistical analysis plans, clinical development plans, pre-review of regulatory documents, FDA interactions, and advisory committee meetings

 

Dr. Johnson has nearly 30 years of experience with biostatistics in the pharmaceutical industry, including more than 20 years as a statistical consultant, advising clients on both statistical and regulatory aspects of clinical development programs. She previously spent 8 years at the FDA as a group leader and statistical reviewer in the Division of Biometrics. At PharmaNet, Dr. Johnson has managed statistical analysis and programming activities for clinical trials in numerous successful NDA/PLA submissions. She has developed statistical analysis plans for studies in most therapeutic areas as well as studies for devices and combination products. Dr. Johnson has authored dozens of publications and presentation for major journals and conferences.

 

PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390