GONNIE VAN OSTA

Gonnie van Osta was born in 1962 in Goes, a small city in the south-west of the Netherlands. After finishing secondary school, she moved to Amsterdam to study physical education at the Vrije Universiteit. After realizing during the first year that statistics and methodology were her favorite topics, she switched to study mathematics at the University of Amsterdam. She graduated 1988 in mathematical statistics, after an internship at the Central Mathematical Institute writing a MSc thesis on bootstrapping methods to predict highwater levels along the Dutch coast.

Agricultural Mathematical Institute

From 1989 to 1991 Gonnie further specialized in applied statistics as a statistical consultant for the Agricultural Mathematics Group in Wageningen supporting the Veterinary Institute in Lelystad and the Research Institute for Pig Husbandry in Rosmalen.

Pharma: Organon (now part of Merck)

In 1992 Gonnie van Osta continued her work as a statistician in the biometrics department of Organon. In the 15 years as an Organon biometrics employee she worked as a statistician and biometrics manager for a variety of indications (Women’s Health, CNS (Psychosis, Sleep), Rheumatoid Arthritis) applying a wealth of statistical methods (experimental design, binary and ordered categorical data, bioassay, mixed modelling, survival analysis, meta-analysis) as well as exploratory data techniques. For 7 years she was a member of the board of the Dutch pharmaceutical statistics and data management (PSDM) working group and in that function a council member of the EFPSI (European Federation of Statisticians in the Pharmaceutical Industry).  In that role she organized regular scientific meetings and courses on statistical topics for this peer group. She has a broad understanding of the drug development (regulatory) requirements, extensive knowledge of ICH, EMA and FDA guidelines and hands-on experience in applying these guidelines. Following the Schering-Plough and Merck mergers, she broadened her scope, experience and responsibilities in various clinical, regulatory and pharmaceutical development functions.

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Lean Six Sigma Black Belt

During her time in the Pharmaceutial Development Department of MSD in Oss, Gonnie lead the interdiciplinary SWIFT (Simplifying Workprocesses to Implement Fast Track) project. This project lead to her Lean Six Sigma Black Belt certifcation. In this role she coached a number of colleagues in their Green Belt certification process. 

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From 2014 onwards Gonnie van Osta works as a statistical consultant, providing input and design justifications for a variety of clinical trials, method comparison studies for medical devices as well as leading integrated statistical analyses for regulatory filings.

Working experience:

• Current: Statistical Consultant

• July 2014 – Jan 2021: Statistician Consultant AUTHOR! Data Analysis and Medical Writing, Hilversum.

• July 2011-June 2014: Director Project Management, Pharmaceutical Sciences and Clinical Supplies, MSD Oss

• March 2009-June 2011: Head Global Regulatory Operations MSD, Oss

• August 2007-February 2009: Senior Clinical Research Scientist at Schering-Plough, Oss

• July 2006-July 2007: Director Clinical Quality at Organon, Oss

• December 1999 – June 2006: Associate Director at Biometrics at Organon, Oss

• April 1995 - November 1999: Project Statistician at Biometrics at Organon, Oss

• January 1992 – March 1995: Statistician at Biometrics, Organon, Oss, the Netherlands

• January 1989 – December 1991: Statistical Consultant at the Agricultural Mathematics Group in Wageningen

Tools

SAS, nQuery

In-depth knowledge of ICH Guidelines, EMA and FDA guidances

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Private

Gonnie van Osta lives in ‘s-Hertogenbosch with her husband who is a secondary school teacher. She enjoys walking, cycling and sings in 3 choirs.