Michael Goedecke, Ph.D.
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Michael Goedecke, Ph.D. Email & Phone Number

Mathematical and statistical modeler with life science and software validation experience at Certara
Location: Raleigh-Durham-Chapel Hill Area, United States, United States 7 work roles 2 schools
1 work email found @certara.com 1 phone found area 919 LinkedIn matched
✓ Verified May 2026 4 data sources Profile completeness 100%

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Work email m****@certara.com
Direct phone (919) ***-****
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Current company
Certara
Role
Mathematical and statistical modeler with life science and software validation experience
Location
Raleigh-Durham-Chapel Hill Area, United States, United States

Who is Michael Goedecke, Ph.D.? Overview

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Michael Goedecke, Ph.D. is listed as Mathematical and statistical modeler with life science and software validation experience at Certara, based in Raleigh-Durham-Chapel Hill Area, United States, United States. AeroLeads shows a work email signal at certara.com, phone signal with area code 919, and a matched LinkedIn profile for Michael Goedecke, Ph.D..

Michael Goedecke, Ph.D. previously worked as Pharmacometrician and Biostatistician (through July 2024) at Certara and Senior Scientist, QbD Lead at Thermo Fisher Scientific. Michael Goedecke, Ph.D. holds Ph.D., Biomathematics, With Statistics Minor from North Carolina State University.

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*@certara.com
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Profile bio

About Michael Goedecke, Ph.D.

I am a mathematical modeler and statistician with experience in process improvement, manufacturing, and quality by design (QbD) in the pharmaceutical industry. I am a highly skilled technical writer, known for conciseness and clarity when explaining and interpreting technical information to audiences with varied backgrounds. I enjoy solving problems, resolving issues, and learning new science. I am equally effective working independently or collaborating as a member of a team.I design and analyze experiments to improve processes in both development and cGMP manufacturing of pharmaceutical and recombinant biopharmaceutical products, analyze product stability studies and bioequivalence studies, generate lot acceptance criteria, and model pharmacokinetic and pharmacodynamic data. I am familiar with cGMPs, 21 CFR Part 11, and ICH quality guidelines.Key Skills:Mathematical / Statistical: Design of Experiments (DoE), ANOVA, regression, non-linear mixed models, multivariate analysis, exploratory data analysis, capability analysis, control chartsSoftware: Minitab, R, SAS, NONMEM, JMP, MATLAB, Microsoft Office productsQuality / Regulatory: QbD, cGMP, 21CFR Part 11, ICH guidelines, stability, bioequivalenceContact: goedecke.michael@gmail.comI am currently seeking opportunities as a statistician, pharmacometrician, or modeler, preferably in the Raleigh/Durham, North Carolina area.

Listed skills include Matlab, Statistics, Machine Learning, Biotechnology, and 22 others.

Current workplace

Michael Goedecke, Ph.D.'s current company

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Certara
Certara
Mathematical and statistical modeler with life science and software validation experience
Princeton, NJ
Website
certara.com
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7 roles

Michael Goedecke, Ph.D. work experience

A career timeline built from the work history available for this profile.

Pharmacometrician And Biostatistician (Through July 2024)

Current
Certara

Radnor, Pennsylvania, US

  • Pharmacometrician
  • Developed population pharmacokinetic, PKPD, and exposure-response models for new drug products.
  • Analyzed pharmacometric data, interpreted results, performed QC reviews, and contributed to technical reports.
  • Contributed to modeling and simulation analysis plans for pharmacometrics projects.
  • Collaborated with pharmacologists, pharmacometricians, and statisticians to provide statistical advice as needed.Biostatistician
  • Produced tables, listings, and figures for statistical analyses of clinical trials.
Jan 2022 - Present

Senior Scientist, Qbd Lead

Thermo Fisher Scientific

Waltham, MA, US

  • Patheon is now part of Thermo Fisher Scientific.Applied Quality by Design principles and knowledge of ICH Quality guidelines, statistical and mathematical modeling, and experimental design to support process.
  • Designed experiments, analyzed results, and optimized processes for new pharmaceutical products, including active pharmaceutical ingredients (APIs), oral solid dosages, and sterile injectables.
  • Analyzed pharmaceutical stability studies to determine shelf life for new products.
  • Explained and interpreted output of statistical and quantitative analyses to audiences with varied backgrounds.
  • Provided expert statistical and mathematical support, assisting internal customers with statistical questions.
  • Delivered scientific and statistical input for out-of-specification (OOS) and other investigations.
Mar 2017 - Dec 2021

Validation Specialist

Ofni Systems
  • Wrote functional requirements, system design specifications, and IQ, OQ, and PQ test protocols for computer software validation, including for 21 CFR Part 11 compliance.
  • Designed, troubleshot, and validated Excel spreadsheets. Diagnosed and resolved spreadsheet problems.
  • Provided quality control review of statistical analysis plans.
  • Tested and documented software for internal and external customers.
Jan 2015 - May 2016

Career Break

Career break to pursue international adoption and integration of our daughter into our family.

Sep 2012 - Jan 2015

Mathematical Modeler / Statistician

Rti International

Research Triangle Park, NC, US

Mathematical modeler and computer programmer. Built epidemiological models for the spread of infectious diseases. Modeled pharmacokinetic data. Built neural network.Specialties: stochastic models, mathematical biology, epidemiology, statistics, experimental design, multivariate analysis, AnyLogic, MATLAB, SAS JMP.

Feb 2005 - Sep 2012

Graduate Student

North Carolina State University

Developed sophisticated skills in biomathematics while studying stochastic modeling.Coached and taught students (as a teaching assistant) in various biomathematics and statistics classes.

Jan 1999 - May 2005

Fermentation Research Associate

Amgen

Thousand Oaks, CA, US

Fermentation Research Associate (1994 - 1998):Designed, implemented, and analyzed experiments to develop microbial fermentation processes for new products and to improve processes and resolve technical issues for Commercial Manufacturing.Fermentation Manufacturing Associate (1989 - 1994):Executed microbial fermentation batches producing commercial drug.

Oct 1988 - Aug 1998
Team & coworkers

Colleagues at Certara

Other employees you can reach at certara.com. View company contacts →

DS Daniel Schindler Daniel Schindler Colleague at Certara Horsham, Pennsylvania, United States, United States View → GA Gwynne Adams Gwynne Adams Colleague at Certara Raleigh-Durham-Chapel Hill Area, United States View → JM Jaap Mandema Jaap Mandema Colleague at Certara Manhattan Beach, California, United States, United States View → RW Roeland Wasmann Roeland Wasmann Colleague at Certara Cape Town, Western Cape, South Africa, South Africa View → AE Aaron Endsley Aaron Endsley Colleague at Certara Greater Seattle Area, United States, United States View → HM Heather Maness Heather Maness Colleague at Certara St Charles, Missouri, United States, United States View → AP Amita Pansari Amita Pansari Colleague at Certara United Kingdom, United Kingdom View → TS Trevor Standish Trevor Standish Colleague at Certara Greater Boston, United States, United States View → BU Benjamin Undefined Benjamin Undefined Colleague at Certara London, Ontario, Canada, Canada View → KS Krithika Shetty Krithika Shetty Colleague at Certara Toronto, Ontario, Canada, Canada View →
2 education records

Michael Goedecke, Ph.D. education

Ph.D., Biomathematics, With Statistics Minor

North Carolina State University

Bs, Biology

Caltech
FAQ

Frequently asked questions about Michael Goedecke, Ph.D.

Quick answers generated from the profile data available on this page.

What company does Michael Goedecke, Ph.D. work for?

Michael Goedecke, Ph.D. works for Certara.

What is Michael Goedecke, Ph.D.'s role at Certara?

Michael Goedecke, Ph.D. is listed as Mathematical and statistical modeler with life science and software validation experience at Certara.

What is Michael Goedecke, Ph.D.'s email address?

AeroLeads has found 1 work email signal at @certara.com for Michael Goedecke, Ph.D. at Certara.

What is Michael Goedecke, Ph.D.'s phone number?

AeroLeads has found 1 phone signal(s) with area code 919 for Michael Goedecke, Ph.D. at Certara.

Where is Michael Goedecke, Ph.D. based?

Michael Goedecke, Ph.D. is based in Raleigh-Durham-Chapel Hill Area, United States, United States while working with Certara.

What companies has Michael Goedecke, Ph.D. worked for?

Michael Goedecke, Ph.D. has worked for Certara, Thermo Fisher Scientific, Ofni Systems, Rti International, and North Carolina State University.

Who are Michael Goedecke, Ph.D.'s colleagues at Certara?

Michael Goedecke, Ph.D.'s colleagues at Certara include Daniel Schindler, Gwynne Adams, Jaap Mandema, Roeland Wasmann, and Aaron Endsley.

How can I contact Michael Goedecke, Ph.D.?

You can use AeroLeads to view verified contact signals for Michael Goedecke, Ph.D. at Certara, including work email, phone, and LinkedIn data when available.

What schools did Michael Goedecke, Ph.D. attend?

Michael Goedecke, Ph.D. holds Ph.D., Biomathematics, With Statistics Minor from North Carolina State University.

What skills is Michael Goedecke, Ph.D. known for?

Michael Goedecke, Ph.D. is listed with skills including Matlab, Statistics, Machine Learning, Biotechnology, Validation, Mathematical Modeling, Data Analysis, and Experimental Design.

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