JungAh Jung

PhD lead statistician with 18 years clinical statistics experience with pharmaceutical companies. Extensive hands-on experience in all aspects of statistical activities including designing, conducting, and reporting all phase of clinical trials (I - IV) and publication support. Experience leading NDA activities for 1 neuropsychiatry compound and interaction with global health authorities (FDA and EMA). Experience as program lead statistician and contributing to strategy discussion cross functional settings. Strong interpersonal and communication skills with the ability to effectively represent biostatistics to project teams and senior management. Experience working in Oncology, CNS, and rare disease therapeutic areas.

• Intern graduate associate presentation at Merck Research Labs, Merck & Co., Inc. Rahway, NJ, August 2005. Assessing PK-AE Relationship with Cumulative Instantaneous Log-Odds Ratio.
• Poster presentation at the XXIIIth International Biometric Conference in Montréal, Canada, July 16-21, 2006. Survival Instantaneous Log-Odds Ratio from Empirical Functions.
• Poster presentation at the Joint Statistical Meetings in Seattle, Washington, August 6-10, 2006 Survival Instantaneous Log-Odds Ratio from Empirical Functions.
• Goldberg SL, Fenaux P, Craig MD, Gyan E, Lister J, Kassis J, Jung J et al. Phase 2 Study of MLN8237, an Investigational Aurora A Kinase (AAK) Inhibitor in Patients with Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS). American Society of Hematology Annual Meeting, Abstracts 2010;116: Abstract 3273.
• Friedberg JW, Mahadevan D, Jung J et al. Phase 2 Trial of Alisertib (MLN8237), an investigational, potent inhibitor of aurora A kinase (AAK), in patients (pts) with aggressive B-and T-cell non-Hodgkin Lymphoma (NHL). The 11th International Congress on Malignant Lymphoma, Lugono, Switzerland, June 2011 and the American Society of Hematology Meeting, San Diego, CA Dec 2011.
• Falchook GS, Zhou X, Rosen LS, Venkatakrishnan K, Kurzrock R, Goldman JW, Jung J et al. Food effect study of the investigational Aurora A Kinase (AAK) inhibitor MLN8237 (alisertib) in patients with advanced solid tumors. European Society for Medical Oncology (ESMO) 2012 Poster presentation.
• Almhanna K, Messersmith WA, Ahnert JR, Cruz C, Ryan DP, Faris JE, Jung J et al. MLN0264, an investigational, first-in-class antibody-drug conjugate (ADC) targeting guanylyl cyclase C (GCC): Phase 1, first-in-human study in patients (pts) with advanced gastrointestinal (GI) malignancies expressing GCC. The 2013 ASCO Annual Meeting, abstract #111779.
• Cruz C, Almhanna K, Messersmith WA, Ahnert JR, Ryan DP, Jung J et al. MLN0264, an investigational anti-guanylyl cyclase C (GCC) antibody-drug conjugate (ADC), in patients (pts) with advanced gastrointestinal (GI) malignancies: Phase I study The 2014 ASCO Annual Meeting, abstract # 3546

• Jung J and Drane JW (2007). Survival instantaneous log-odds ratio from empirical functions. The International Journal of Biostatistics; 3(1), Article 7.
• Cervantes A, Elez E, Roda D, Ecsedy J, Macarulla T, Venkatakrishnan K, Rosell S, Andreu J, Jung J et al (2012). Phase I Pharmacokinetic/Pharmacodynamic Study of MLN8237, an Investigational Oral, Selective Aurora A Kinase Inhibitor, in Patients with Advanced Solid Tumors. Clinical Cancer Research; 18: 4764-4774.
• Friedberg JW, Mahadevan D, Cebula E, Persky D, Lossos I, Agarwal AB, Jung J, Burack R, Zhou X, Leonard EJ, Fingert H, Danaee H, Bernstein SH (2014). Phase II study of alisertib, a selective aurora A kinase inhibitor, in relapsed and refractory aggressive B- and T-Cell non-hodgkin lymphomas. Journal of clinical oncology; 32(1):44-50.
• Goldberg SL, Fenaux P, Craig MD, Gyan E, Lister J, Kassis J, Pigneux A, Schiller GJ, Jung J, Leonard EJ, Fingert H, Westervelt P (2014). An exploratory phase 2 study of investigational Aurora A kinase inhibitor alisertib (MLN8237) in acute myelogenous leukemia and myelodysplastic syndromes Leukemia Research Reports; 3:58-61.
• Falchook GS, Venkatakrishnan K, Sarantopoulos J, Kurzrock R, Mita AC, Fu S, Mita MM, Zhou X, Jung J et al (2015). Relative bioavailability study of a prototype oral solution formulation of the Aurora A kinase inhibitor alisertib (MLN8237) in patients with advanced solid tumors. International Journal of Clinical Pharmacology and Therapeutics; 53(7):563-72.
• Falchook GS, Zhou X, Venkatakrishnan K, Kurzrock R, Mahalingam D, Goldman JW, Jung J, Ullmann CD, Milch C, Rosen LS, Sarantopoulos J (2016). Effect of Food on the Pharmacokinetics of the Investigational Aurora A Kinase Inhibitor Alisertib (MLN8237) in Patients with Advanced Solid Tumors. Drugs in R&D; 16(1):45-52.
• Almhanna K, Kalebic T, Cruz C, Faris JE, Ryan DP, Jung J, Wyant T, Fasanmade AA, Messersmith W, Rodon J (2016). Phase I Study of the Investigational Anti-Guanylyl Cyclase Antibody-Drug Conjugate TAK 264 (MLN0264) in Adult Patients with Advanced Gastrointestinal Malignancies. Clin Cancer Res;22(20):5049-5057.
• Chung S, Sinha SR, Shah A, Stern JM, Cheng H, Jung J, Grinnell T, Blum D (2019) Long-term safety and efficacy following conversion to eslicarbazepine acetate monotherapy in adults with focal seizures. Epilepsy Research; volume 153:59-65
• Bardia A, Aftimos P, Bihani T, Anderson-Villaluz A, Jung J, Conlan M, Kaklamani G (2019). EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer. Future Oncology; volume 15; no 28; 3209-3218
• Clayton A, Lasser R, Parikh S, Iosifescu D, Jung J, Kotecha M, Forrestal F, Jonas J, Kanes S, Doherty J (2023). Zuranolone for the treatment of adults with major depressive disorder: A randomized, placebo‐controlled phase 3 trial. The American Journal of Psychiatry; 180(9):676-684
• Parikh A, Aaronson S, Mathew J, Gustavo A, DeBattista C, Kanes, S, Lasser, R, Bullock A, Kotecha M, Jung J, et al (2023.) Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3 CORAL study. American College of Neuropsychopharmacology