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Hire Dr. Gary H.

United States

USD 130 /hr

Ph.D. statistician with a strong interest in the life sciences.

Profile Summary

• Extensive experience in all stages of statistical support for research from study design and sample size planning through publication, as well as submissions to regulatory agencies. • Use of Real World Data / Real World Evidence. • Extensive experience in all phases of clinical development for pharmaceutical and biotech products, from Phase I through post-approval safety analysis. • Solid knowledge of study design and analysis, including adaptive designs, Bayesian methods, meta-analysis, and indirect treatment comparison. • Experienced in clinical research in the following therapeutic areas: respiratory, gastrointestinal, central nervous system, cardiovascular, oncology, vaccines, ophthalmology, and anti-infectives. • Extensive experience working with Contract Research Organizations (CROs), reviewing vendor statistical analysis plans and programmed output for clinical projects. • Strong computer skills, including expert knowledge of SAS, and knowledge of R and R-Studio.

Subject Matter Expertise

• ★ Biostatistics
• ★ Applied Statistics
• ☆ Statistics
• ☆ Meta-Analysis
• ☆ Regression Analysis
• ☆ Nonlinear Regression
• ☆ Bayesian Statistics
• ☆ Study Design
• ☆ Statistical Review
• ☆ Health Data Analysis
• ☆ SAS
• ☆ R
• ☆ Drug Development
• ☆ Drug Efficacy Testing

Services

• Writing
• Data & AI

Writing Clinical Trial Documentation

Data & AI Statistical Analysis, Data Insights

Work Experience

Consultant

Insmed (United States)

December 2024 - December 2025

Statistics Director

Takeda (United States)

January 2017 - July 2024

Associate Biostatistics Director

Astellas Pharma (United States)

October 2006 - January 2017

Consultant

Genentech

September 2003 - October 2006

Consultant

Pharmacia

2001 - 2003

Consultant

Fujisawa Healthcare

2000 - 2000

Consulting Statistician

G. D. Searle & Company

1989 - 1998

Education

Ph.D. (Statistics)

Northwestern University

1998 - 2002

M.S. (Statistics)

University of Illinois Urbana-Champaign

1987 - 1988

MS (Biology)

Kent State University

1982 - 1985

BA (Biology)

Wartburg College

1978 - 1982

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

Gary Hantsbarger, Chitra Karki, Erika Turkstra, Elisabetta Fenu, Ken Genenz, Inmaculada Gilaberte, Julián Panés (2024). Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in patients with complex perianal fistulas in Crohn’s disease . BMC Gastroenterology.

(2024). Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in patients with complex perianal fistulas in Crohn's disease . BMC GASTROENTEROLOGY.

Gary Hantsbarger, Chitra Karki, Amod Athavale, Vijay Abilash, Parnia Geransar, Kate Lee, Slobodan Milicevic, Marko Perovic, Leanne Raven, Magdalena Sajak-Szczerba, et al. (2023). Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn’s perianal fistulas . World Journal of Gastrointestinal Surgery.

Gary Hantsbarger, Chitra Karki, Amod Athavale, Vijay Abilash, Parnia Geransar, Kate Lee, Slobodan Milicevic, Marko Perovic, Leanne Raven, Magdalena Sajak-Szczerba, et al. (2023). Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn’s perianal fistulas . World Journal of Gastrointestinal Surgery.

Gary Hantsbarger, Chitra Karki, Amod Athavale, Vijay Abilash, Parnia Geransar, Kate Lee, Slobodan Milicevic, Marko Perovic, Leanne Raven, Magdalena Sajak-Szczerba, et al. (2023). Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn’s perianal fistulas . World Journal of Gastrointestinal Surgery.

Gary Hantsbarger, Chitra Karki, Dominick Latremouille-Viau, Inmaculada Gilaberte, Hela Romdhani, Amy L. Lightner (2023). Disease Burden, Treatment Patterns, and Economic Impact of Rectovaginal Fistulas in Patients with Crohn’s Disease: Findings from a Retrospective, Observational, Longitudinal Study Based on US Claims Databases . PharmacoEconomics - Open.

Gary Hantsbarger, Chitra Karki, Dominick Latremouille-Viau, Inmaculada Gilaberte, Hela Romdhani, Amy L. Lightner (2023). Disease Burden, Treatment Patterns, and Economic Impact of Rectovaginal Fistulas in Patients with Crohn’s Disease: Findings from a Retrospective, Observational, Longitudinal Study Based on US Claims Databases . PharmacoEconomics - Open.

(2023). Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn's perianal fistulas . WORLD JOURNAL OF GASTROINTESTINAL SURGERY.

(2023). Disease Burden, Treatment Patterns, and Economic Impact of Rectovaginal Fistulas in Patients with Crohn's Disease: Findings from a Retrospective, Observational, Longitudinal Study Based on US Claims Databases . PHARMACOECONOMICS-OPEN.

Panés J, Bouma G, Ferrante M, Kucharzik T, Nachury M, de la Portilla de Juan F, Reinisch W, Selvaggi F, Tschmelitsch J, Brett NR, et al. (2022). INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn's Disease Treated in the ADMIRE-CD Trial . Inflammatory bowel diseases.

(2022). Discrete choice experiment to examine patient preferences for surgical interventions in patients with Crohn's perianal fistulas: results from a global burden of illness study. JOURNAL OF CROHNS & COLITIS.

(2022). Examining faecal incontinence and its impact on health-related quality of life in patients with Crohn's perianal fistulas: results from a multi-country burden of illness study. JOURNAL OF CROHNS & COLITIS.

(2022). HIGH SYMPTOM BURDEN AND IMPACT ON HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH CROHN'S PERIANAL FISTULAS: RESULTS FROM A GLOBAL BURDEN OF ILLNESS STUDY. GASTROENTEROLOGY.

(2022). HIGHER WORK IMPAIRMENT AND INCREASED HEALTHCARE RESOURCE UTILIZATION IN PATIENTS WITH CROHN'S PERIANAL FISTULA: RESULTS FROM A GLOBAL BURDEN OF ILLNESS STUDY. VALUE IN HEALTH.

(2022). High symptom burden and impact on health-related quality of life in patients with Crohn's perianal fistulas: results from a global burden of illness study. JOURNAL OF CROHNS & COLITIS.

(2022). INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn's Disease Treated in the ADMIRE-CD Trial . INFLAMMATORY BOWEL DISEASES.

M Maruszczak, K Genenz, E Turkstra, E Fenu, G Hantsbarger, I Gilaberte, C Karki, J Panes (2021). DOP57 Predictive modelling to examine long term treatment effectiveness of darvadstrocel in patients with complex perianal fistulas in Crohn’s Disease . Journal of Crohn's and Colitis.

M Maruszczak, K Genenz, E Turkstra, E Fenu, G Hantsbarger, I Gilaberte, C Karki, J Panes (2021). DOP57 Predictive modelling to examine long term treatment effectiveness of darvadstrocel in patients with complex perianal fistulas in Crohn’s Disease . Journal of Crohn's and Colitis.

(2021). Investigating fatigue in vedolizumab-treated patients with ulcerative colitis or Crohn's disease from a Belgian registry . JOURNAL OF CROHNS & COLITIS.

(2021). Predictive modelling to examine long term treatment effectiveness of darvadstrocel in patients with complex perianal fistulas in Crohn's Disease . JOURNAL OF CROHNS & COLITIS.

E Louis, V Muls, P Bossuyt, A Colard, A Nakad, D Baert, F Mana, P Caenepeel, S Vanden Branden, S Vermeire, et al. (2020). P600 Vedolizumab dose optimisation: Findings from a Belgian registry . Journal of Crohn's and Colitis.

(2020). Vedolizumab dose optimisation: Findings from a Belgian registry. JOURNAL OF CROHNS & COLITIS.

(2020). Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data . ALIMENTARY PHARMACOLOGY & THERAPEUTICS.

(2019). Effectiveness and safety of vedolizumab maintenance therapy for inflammatory bowel disease: findings from a Belgian registry . JOURNAL OF CROHNS & COLITIS.

(2019). VEDOLIZUMAB USE IS NOT ASSOCIATED WITH INCREASED MALIGNANCY INCIDENCE: GEMINI LONG-TERM SAFETY STUDY RESULTS AND POST-MARKETING DATA. GASTROENTEROLOGY.

(2019). Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data . JOURNAL OF CROHNS & COLITIS.

(2018). SAFETY OF VEDOLIZUMAB IN PATIENTS NAIVE TO TREATMENT WITH TNF ANTAGONISTS COMPARED WITH PATIENTS WITH PRIOR USE OF TNF ANTAGONISTS. GASTROENTEROLOGY.

(2018). Safety of vedolizumab in patients naive to treatment with TNF antagonists compared with patients with prior use of TNF antagonists. JOURNAL OF CROHNS & COLITIS.

(2013). Randomized, Double-Masked, Placebo-Controlled Study to Assess the Ocular Safety of Mirabegron in Healthy Volunteers . JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS.

(2012). Randomised, double-blind, placebo-controlled study to assess the ocular safety of mirabegron in normotensive IOP research subjects. EUROPEAN UROLOGY SUPPLEMENTS.

(1997). Misoprostol (M) in the treatment of NSAID-induced gastric ulcers (GU) while NSAID therapy is continued. GASTROENTEROLOGY.