Quality Control Market Access
Resume:
SUNALI GOONESEKERA, MS
** ******* ****** #* • Boston • MA • 02130 • 617-***-**** • *******@*****.*** Summary of Qualifications as Epidemiologist:
Senior epidemiologist with over 12 years of experience leading observational and real-world evidence (RWE) studies and data analytics in both biopharma and consulting settings. Expertise spans rare and chronic diseases, HIV, registry data management, global disease forecasting, literature reviews, and claims/EHR analysis using SAS and SQL. Core Competencies:
Observational Study Design; Rare & Chronic Disease Epidemiology; SAS, SQL, STATA, SUDAAN; Claims and EHR data analysis; Literature reviews & Medical Writing; Real-World Evidence; Cross-Functional Collaboration; Publication Strategy; Global Burden Forecasting; Team Leadership.
Professional Experience:
Contract Senior Epidemiologist
Alexion Pharmaceuticals Inc., Boston, MA
April 2023-present
• Led epidemiologic strategy and deliverables for the atypical hemolytic uremic syndrome (aHUS) registry, supporting regulatory submissions and publication planning.
• Provided expert epidemiology support to internal stakeholders.
• Contributed to registry projects including quality-of-life assessments, genetic profile analyses, and long-term treatment outcomes.
• Directed external vendor collaborations and conducted data quality reviews using SAS for aHUS and generalized myasthenia gravis (gMG) registries.
• Participated in publications strategy developments and authored/edited statistical analysis plans and regulatory documents. Senior Manager, Epidemiology
Clarivate (previously Decision Resources Group), Boston, MA April 2020-March 2023
• Led and mentored a team of three epidemiologists responsible for conducting global disease burden studies across cardiovascular, metabolic, oncology, infectious disease, and autoimmune indications.
• Delivered high-quality client presentations on methodology, feasibility, and study findings.
• Conducted department trainings on epidemiological methodology, report writing, data analysis, and quality control.
• Cardiovascular epidemiology therapy area lead; expertise in metabolic, autoimmune, and rare diseases.
• Presented findings at conferences.
• Authored peer-reviewed publications and abstracts; presented at national conferences.
• Conducted data analysis using SAS and SQL across claims and EHR sources. Epidemiologist
Decision Resources Group, Boston, MA
March 2015-March 2020
• Forecasted disease trends based on risk factors, vaccine and drug uptake patterns and healthcare access in global markets.
• Conducted analyses on hospital, claims, and electronic health record databases.
• Validated epidemiological models.
• Presented epidemiological findings to clients.
Sr. Research Associate
New England Research Institutes, Watertown, MA
March 2014-Feb. 2015
• Designed and conducted studies on biogeographic ancestry, diabetes disparities, and obesity using Boston Area Community Health (BACH) Survey data. Lead authored two peer-reviewed manuscripts.
• Conducted a comprehensive literature review on Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID) outcomes for pharmaceutical client.
Project Manager II, Mini-Sentinel Pilot (www.mini-sentinel.org) SUNALI GOONESEKERA, MS
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42 Newbern Street #3 • Boston • MA • 02130 • 617-***-**** • *******@*****.*** Mini-Sentinel Operations Center (MSOC), Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA J July 2012-March 2014
• Managed deliverables for FDA’s post-market safety surveillance program.
• Drafted reports to FDA on workgroup findings; organized webinars and stakeholder communications. April 2009-June 2014
• Conducted analyses on inflammation, prostate and liver cancer, and HIV treatments.
• Authored scientific reviews and database entries for Alzrisk.org.
• Teaching assistant and tutor for epidemiology graduate courses (2009-2011). Education:
S.M. in Epidemiology, Harvard School of Public Health – Boston, MA (2005-2008) Concentration: Infectious Disease Epidemiology
Master’s Thesis: Host iron metabolism and tuberculosis susceptibility Passed the qualifying exam for the DSc program in Epidemiology at Harvard. A.B. in Biology with Honors, Dartmouth College, Hanover, NH (1990-1994) Thesis: Cancer and DNA Repair: Functional significance of the Human O6-methylguanine DNA methyltransferase gene C-terminus Awards: Departmental Honors, biology, Tucker Fellow – Contributions to at-risk pre-adolescents JOURNAL AND WEBSITE PUBLICATIONS
Peer-reviewed Publications
Goonesekera SD, Dey S, Thakar S, Davila EP. Racial/ethnic differences in autoimmune disease prevalence in US claims/EHR Data. American Journal of Managed Care. 2024 Jan; 30(1): 294-e300. doi: 10.37765/ajmc.2024.89488. Goonesekera S, Rudnicka-Noulin D, Isherwood A. The burden of heart failure in North America and Western Europe. Future Cardiology. 2020. doi: 10.2217/fca-2020-0097.
Xu, S, Shetterly S, Cook A, Raebel,M, Goonesekera S, Shoaibi,A, Roy J, Fireman B. Evaluation of propensity scores, disease risk scores, and regression in confounder adjustment for the safety of emerging treatment with group sequential monitoring. Pharmacoepidemiology and Drug Safety. 2016 Feb 15; 25(4): 453-461. Goonesekera SD, Yang MH, Hall SA, Fang SC, Piccolo RS, McKinlay JB. Racial ethnic differences in type 2 diabetes treatment patterns and glycaemic control in the Boston Area Community Health Survey. BMJ Open. 2015 May 12;5(5):e007375. doi: 10.1136/bmjopen-201*-******.
Goonesekera SD, Fang SC, Piccolo RS, Florez JC, McKinlay JB. Biogeographic ancestry is associated with higher total body adiposity among African-American females: the Boston Area Community Health Survey. PLoS One. 2015 Apr 13;10(4):e0122808. doi: 10.1371/journal.pone.0122808. eCollection 2015. Baker MA, Wilson D, Wallengren K, Sandgren A, Iartchouk O, Broodie N, Goonesekera SD, Sabeti PC, Murray MB. Polymorphisms in the gene that encodes the iron transport protein ferroportin 1 influence susceptibility to tuberculosis. J Infect Dis. 2012 Apr; 205(7):1043-7.
Baker MA, Harries AD, Jeon CY, Hart JE, Kapur A, Lönnroth K, Ottmani SE, Goonesekera S, Murray MB. The impact of diabetes on tuberculosis treatment outcomes: a systematic review. BMC Medicine. 2011 July; 9(1) : 81. Jeon CY, Harries AD, Baker MA, Hart JE, Kapur A, Lönnroth K, Ottmani SE, Goonesekera S, Murray MB. Bi-directional screening for tuberculosis and diabetes: a systematic review. Tropical Med Intl Health. 2010 Nov.; 15(11) : 1300-14. Goldstone RM, Goonesekera SD, Bloom BR, Sampson SL. The transcriptional regulator Rv0485 modulates the expression of a PE and PPE gene pair and is required for Mycobacterium tuberculosis virulence. Infect Immun. 2009 Oct.; 77(10):4654-67. SUNALI GOONESEKERA, MS
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42 Newbern Street #3 • Boston • MA • 02130 • 617-***-**** • *******@*****.*** Garcia-Contreas L, Wong YL, Mutti P, Padilla D, Sadoff J, Drousse J, Germishuizen WA, Goonesekera S, Elbert K, Bloom BR, Miller R, Foune PB, Hickey A, and Edwards D. Immunization by a bacterial aerosol. PNAS. 2008 March 25; 105(12):4656-60. Wong YL, Sampson S, Germishnizen W A, Goonesekera S, Coponetti G, Sadoff J, Bloom B, and Edwards D. Drying a tuberculosis vaccine without freezing. PNAS. 2007 Feb. 20; 104(8): 2591-5. Mabley JG, Pacher P, Bai P, Wallace R, Goonesekera S, Virag L, Southan GJ, Szabo C. Suppression of intestinal polyposis in Apcmin/+ mice by targeting the nitric oxide or poly(ADP-ribose) pathways. Mutat Res. 2004 Apr. 14; 548(1-2): 107-16. Murthy KGK, Deb A, Goonesekera S, Szabo C, Salzman AL. Identification of conserved domains in Salmonella muenchen flagellin that are essential for their ability to activate TLR5 and to induce an inflammatory response in vitro. J Biol Chem. 2004 Feb. 13; 279(7): 5667-75.
Kim S, Dubelman AM, Goonesekera S, Feig LA, and Baleja JD. 1H, 15N, and 13C NMR resonance assignments for the Eps 15 homology domain of Reps 1. Journal of Biomolecular NMR. 2000 Dec.; 18(4): 367-8. Freshney N, Goonesekera S and Feig L. Activation of exchange factor Ras-GRF by calcium requires a functional DBL homology domain. Federation of European Biochemical Societies 1997 Apr. 21; 407(1): 111-5. Buchsbaum R, Telliez J, Goonesekera S and Feig L. The N-terminal pleckstrin, coiled-coil and IQ domains act cooperatively to facilitate activation by calcium. Molecular and Cellular Biology 1996 Sep; 16(9): 4888. Conference Presentations & Abstracts
Goonesekera S. A global epidemiological forecast on Multiple Sclerosis and disease subtypes. American Academy of Neurology Annual Meeting, Boston, 2017.
Goonesekera S & Tadwalkar S. Estimating the diagnosed prevalence of two rare photodermatoses in the United States by race and ethnicity: an analysis using claims data and electronic health records. American Academy of Dermatology Annual Meeting, Boston, 2022.
Goonesekera S & Isherwood A. Global trends in the diagnosed incidence of HIV from 2017 to 2027: effects of changing demographics and pre-exposure prophylaxis use. Society for Epidemiologic Research Annual Meeting, Baltimore, 2018. Goonesekera S, Bansal A, Tadwalkar S, and Isherwood A. The prevalence of systemic sclerosis, dermatomyositis/polymyositis, and giant cell arteritis in the United States by Race and Ethnicity: an analysis using electronic health records [abstract, ACR convergence, 2020]. Arthritis Rheumatol. 2020; 72 (suppl 10).
Journal Reviewer
BMJ Open
Diabetes Research and Clinical Practice
American Journal of Managed Care
BMC Cardiology
BMC Public health
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