ICH E20 Adaptive Designs Working Group @ Expert Working Group Member negotiating and writing ICH E20 guidance (July 2019 - December 2024)
Vice President and Global Head, Data and Statistical Sciences @ (March 2018 - November 2024)
Biopharmaceutical Section Executive Committee @ (January 2014 - December 2019)
Vice President and Global Head, Biostatistics and Data Management @ (January 2013 - February 2018)
Executive Director and Department Head, Biostatistics @ (June 2001 - November 2012)
Faculty Member @ Institute for Professional Education (January 1994 - January 2004)
Consultant @ C. L. McIntosh & Associates (September 1996 - June 2001)
Erik Pulkstenis Education
Pennsylvania State University
PhD (Statistics)
1991-1996
Erik Pulkstenis Skills
21 CFR Part 11
Biopharmaceuticals
Biostatistics
Biotechnology
CDISC
CRO
CTMS
Clinical Data Management
Clinical Development
Clinical Research
Clinical Study Design
Clinical Trials
Commercialization
Data Management
Drug Development
EDC
FDA
GCP
Immunology
Infectious Diseases
Life Sciences
Lifesciences
Medical Devices
Oncology
Pharmaceutical Industry
Protocol
Regulatory Submissions
SAS
SOP
Therapeutic Areas
Vaccines
Leadership
Customer Service
Higher Education
Sales
Training
Marketing
Public Speaking
Support
DMC
Social Media
Teaching
Strategic Planning
Erik Pulkstenis Summary
Erik Pulkstenis, based in Chicago, IL, US, is currently a Senior Vice President, Biometrics at Annexon Biosciences. Erik Pulkstenis brings experience from previous roles at CDISC, Biopharmaceutical Statistics Leaders Consortium, Expert Working Group Member negotiating and writing ICH E20 guidance and AbbVie. Erik Pulkstenis holds a 1991 - 1996 PhD in Statistics @ Pennsylvania State University. With a robust skill set that includes 21 CFR Part 11, Biopharmaceuticals, Biostatistics, Biotechnology, CDISC and more. Erik Pulkstenis has 1 emails and 1 mobile phone numbers on RocketReach.
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