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Statistical Analysis Project Manager

Location:
Irvine, CA
Salary:
160,000
Posted:
August 31, 2023

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Resume:

Lisa Le

Irvine, California

714-***-****

adzdf2@r.postjobfree.com

OVERALL EXPERIENCE

Experience with real-world data, and clinical trial, continuous data analysis, categorical data analysis, linear regression, factor analysis, clustering techniques, repeated measures and survival analysis.

Experience with Time-to-event variables, such as time to diagnosis or treatment or events analyzed using Cox proportional hazard regression. Appropriate techniques used to adjust for variable follow-up time, where appropriate. Knowledge in propensity score matching to reduce sample size of control group in healthcare.

Experience with cost outcomes, analyzed using generalized linear models (GLM) with a gamma distribution and log link. Utilization of healthcare claim measures (e.g., inpatient stays, emergency visits, ambulatory visits) analyzed using negative binomial or logistic regression, depending upon the frequency of events.

In-depth knowledge healthcare claims with experience more than 20 years included medical (diagnosis ICD-9 or ICD-10, CPT, Procedure, HCPCS, Revenue code), pharmacy (NDC), provider (NPI, DEA), patient enrollment and costs of payer, patient paid, out of pocket and coordination of benefits (COB) and other costs. Familiar with line of business included Commercial, Medicaid, Medicare, HMO, PPO. In-depth knowledge of Electronic Health Records (EHR) included biomarker, labs (LOINC Code), SDS, patient reports, measurement, provider and patient discharge.

Knowledge with clinical data, experience more than 8 years, analysis on data captured during Phase I /II/III and phase IV. Randomized Double-Blinded clinical trials, conducted at multiple centers evaluating various doses of an investigational agent against placebo. Created programming specifications documents for creating analysis datasets for both safety and efficacy. Developed analysis datasets for safety and efficacy data.

Used SAS, SQL and SAS Macro to generate tables, listings, graphs, build models, and other information as needed.

In-depth knowledge with univariate edit checks, multivariate edit checks and logic checks,

Always work on multiple projects and multiple tasks and meet timeline earlier than expected.

Additional experience with CMS reports, knowledge with audits from CMS and healthcare effectiveness data and information set (HEDIS). Knowledge of secure delivery of personally identifiable health information (PHI) and/or personally identifiable information (PII) to external parties and health insurance portability and accountability Act (HIPAA).

EDUCATION

1988 MS, Applied Statistics

University of Memphis

Memphis, TN, USA

1987 BS, Applied Math & Physical Science

University of Memphis

Memphis, TN, USA

PROFESSIONAL EXPERIENCE

Jul 2016 to Aug 2023 Senior Lead Analyst/Statistical Programmer

Optum

Eden Prairie, MN, USA

Working with researchers for methodology, sampling, data sources, design from Real-World data.

Constantly worked with healthcare claims included medical (diagnosis ICD-9 or ICD-10, CPT, Procedure, HCPCS, Revenue code), pharmacy (NDC), provider (NPI, DEA), patient enrollment and costs of payer, patient paid, out of pocket and coordination of benefits (COB) and other costs. In-depth knowledge with line of business included Commercial, Medicaid, Medicare, HMO, PPO.

Working with Electronic Health Records (EHR) included diagnosis, procedure, patient prescriptions, patient reports, biomarker, labs (LOINC Code), SDS, patient enrollment, measurement, provider, patient discharge and other related to the therapeutic areas autoimmune, diabetes, cardiovascular, endocrine, renal, pain, mental health, infectious diseases, and oncology.

Work closely with researchers to identify data issues and solutions to the issues.

Create data dictionary, and data verification, tables, and reports.

Execute descriptive and multivariate analysis.

Work within budgeted project hours and report progress back to project manager

Complete project analysis documentation according to department standards

Mentor junior staff for writing project specification, running verification and conducting analysis.

Lead infrastructure initiatives to support department processes.

Develop and maintain standard programs for the department standard library with focus on analytic programs.

Participate in the maintenance of project reference materials and review with new team members.

Performed data analysis/cleanup/management/tables/listings/graphs in SAS and Excel.

Implemented SAS programs to detect outliers, create edits, extract manageable datasets, and imputed missing data.

Aug 2006 to Jun 2016 Senior Biostatistician

Optum

Irvine, CA, USA

Provided statistical analysis for research projects, periodical reports, and ad hoc requests.

Developed and improved quantitative data analytics and reporting of clinical program and Medication Therapy Management Program (MTMP) part D Medicare population, the Centers for Medicare & Medicaid Services (CMS) reports.

Performed data extraction aggregation, quality checks, and analyzed from multiple sources.

Reviewed analytical plan and performs analyses to determine effectiveness of clinical program.

Provided medical and pharmacy claims for MTMP Medicaid population as request.

Analyzed mail penetration rate for chronic maintenance medications across states.

Predictive Medication Adherence for a specific medication class and for a specific member with a known pre adherence condition and the initial fill date pharmacy claim after the index date.

Evaluated Asthma, compared the cost (pharmacy and medical claims) between member compliance and non-compliance.

Evaluated all clinical programs (Narcotic, Interaction Drug Disease, Duplicate Therapy, Specialty Adherence, Generic existing and more)

Worked with other teams and managed potential problems and solving problems.

Updated drug cost, prevalence table and medical claims

Performed data analysis/cleanup/management/tables/listings/graphs in SAS and Excel.

Implemented SAS programs to detect outliers, create edits, extract manageable datasets, and imputed missing data.

Jan 2004 to Aug 2006 Senior Biostatistician

Medtronic MiniMed

Northridge, CA, USA

Developed Statistical Analysis Plans (SAP) documentation, worked with other teams to developed and refined study objectives. Supported the ongoing needs for publications or on an ad-hoc basis.

Worked with other teams to develop specifications for the database design. Participate in the design of case report forms (CRF) and ensure consistency between the data collected and the objectives of the study.

Enforced consistency standardization of statistical methodology, programming standards and data specifications across all studies. Created table shell for all output in standard format.

Calculated sample size and ensured the accurate generation of the randomization treatment assignments.

Interacted with FDA reviewers for statistical analysis, to explain the quantitative results of clinical studies and approach.

Generated results, tables and graphics and worked with medical writer for publication.

Mar 2003 to Dec 2003 Statistical Analysis Programmer

Amgen

Thousand Oak, CA, USA

Created data dictionary, format, and table shell.

Checked output and data from other programmers.

Reviewed analytical plan and results.

Aug 1998 to Feb 2003 Senior Statistician

Integrium CRO

Tustin, CA, USA

Performed tasks as both leader biostatistician and leader SAS programmer to lead the biostatistics and SAS program team on many projects.

Reviewed literature article, designed clinical trials, provided statistical analysis methods.

Designed tables, listing and graph shells; Worked closely with Clinical Team to assist in preparation of Clinical case report forms (CRF).

Jan 1997 to Aug1998 Senior Statistician

University of Southern California

CA, USA

Reviewed articles and provided statistical analysis.

Designed tables, listings, graphs and shells.

Worked closely with professors.

Jan 1989 to Jun 1996 SPSS/SAS Statistical Analysis

University of Memphis

Worked with professors to define and refine study objectives. Supported the ongoing needs for publications or on an ad-hoc basis.

OREIGN LANGUAGES

Vietnamese Speak and Read

PUBLICATIONS/PRESENTATIONS

Halpern R, Mullen W, Gaiazov S, Le L, Wheeler A. Assessment of treatment paths for OUD patients after an acute OUD event. APNA Annual Conference, Long Beach, CA, October 19-22, 2022.

Halpern R, Mullen W, Gaiazov S, Le L, Landis C, Wheeler A. Analysis of treatment paths among patients after an acute opioid related event. AMCP Nexus, National Harbor, MD, October 11-14, 2022.

Fisher DA, Engel-Nitz NM, Miller-Wilson LA, Le L, Limburg P. Patterns of colorectal cancer (CRC) screening rates among the average risk US population. ASCO Gastrointestinal Cancers Symposium, Virtual & San Francisco, CA, January 20-22, 2022.

Lal LS, Aly A, Le LB, Peckous S, Seal B, Teitelbaum A. Healthcare costs related to adverse events in hepatocellular carcinoma treatment: A retrospective observational claims study. Cancer Rep. 2022 May;5(5):e1504. doi: 10.1002/cnr2.1504. Epub 2021 Sep 7.

Patwardhan P, Landsteiner A, Lal LS, Geevarghese L, Le L, Nandal S, Cuker A. Eltrombopag treatment of patients with secondary immune thrombocytopenia: retrospective EHR analysis. Ann Hematol. 2022 Jan;101(1):11-19. doi: 10.1007/s00277-021-04637-2. Epub 2021 Sep 10.

Engel-Nitz N, Miller-Wilson LA, Le L, Limburg P, Fisher D. Patient and Provider Factors associated with Colorectal Cancer Screening in a Large U.S. Claims Database. 18th Annual Meeting of the International Society of Gastrointestinal Oncology, Virtual, October 1-2, 2021.

Swetha R, Palli MS, Anderson AJ, Le L, Buikema AR, Francino-Elder J, Frazer M. Evaluation of Health Care Resource Utilization (HCRU) within Baseline Exacerbation Subgroups Among Patients with COPD Initiating Combination Tiotropium/Olodaterol (TIO+OLO) Versus Triple Therapy (TT). ISPOR Annual European Congress, Milan, Italy (Virtual), November 16-19, 2020.

Aly A, Lal L, Le L, Peckous S, Teitelbaum A. Clinical and economic burden in patients receiving NCCN-recommended systemic therapy for metastatic hepatocellular carcinoma. AASLD Annual Meeting, Virtual, November 13-16, 2020.

Singer D, Paudel ML, Shetty S, Le L, Conoscenti C, Nathan S. Clinical and Demographic Characteristics of Patients with Idiopathic Pulmonary Fibrosis who have Preserved Lung Function. AMCP Nexus, Virtual, October 19-23, 2020.

Cuker A, Landsteiner A, Nandal S, Lal LS, Le L, Geevarghese L, Patwardhan P. Treatment Patterns and Outcomes Associated with Use of Eltrombopag in Patients with Secondary Immune Thrombocytopenia. 2020 European Hematological Association (EHA) 25th Virtual Congress, E-Poster, June 11-14, 2020.

Pawar A, Velcheti V, Lal LS, Le L, Andrade K, Desai I, Patwardhan PPawar A, Velcheti V, Lal LS, Le L, Andrade K, Desai I, Patwardhan P. Retrospective EHR study on effectiveness of eltrombopag in cancer treatment-related thrombocytopenia. 61st ASH Annual Meeting, Orlando, FL, December 7-10, 2019.

Moretz C, Bengtson LGS, Sharpsten L, Koep E, Le L, Tong J, Stanford RH, Hahn B, Ray R. Evaluation of rescue medication use and medication adherence receiving umeclidinium/vilanterol versus tiotropium bromide/olodaterol. Intl J COPD. 2019 Sep 1;14:2047-60.

Moretz C, Sharpsten L, Bengtson LGS, Koep E, Le L, Tong J, Stanford RH, Hahn B, Ray R. Real-world effectiveness of umeclidinium/vilanterol versus fluticasone propionate/salmeterol as initial maintenance therapy for chronic obstructive pulmonary disease (COPD): a retrospective cohort study. Intl J COPD. 2019 Aug 1;14:1721-37.

Han C, Kong R, Stockl K, Lee C, Le L, Lew HC, Solow BK, Lee JS. Cost-effectiveness analysis of a migraine intervention program in a Medicaid population. AMCP 26th Annual Meeting and Expo, Tampa, FL, April 1-4, 2014.

Han C, Kong R, Stockl K, Lee C, Le L, Lew HC, Solow BK, Lee JS. Cost-effectiveness analysis of a migraine intervention program in a Medicaid population. J Manag Care Pharm. 2014 April;20(4-a):S30-31.

Foreman KF, Stockl KM, Le LB, Fisk E, Shah SM, Lew HC, Solow BK, Curtis BS. Impact of a text messaging pilot program on patient medication adherence. Clin Ther. 2012 May;34(5):1084-91.

Foreman KF, Stockl KM, Le LB, Fisk E, Shah SM, Lew HC, Solow BK, Curtis BS. Impact of a text messaging pilot program on patient medication adherence. AMCP 24th Annual Meeting and Expo, San Francisco, CA, April 18-20, 2012.

Erickson SC, Le L, Zakharyan A, Stockl KM, Harada AS, Borson S, Ramsey SD, Curtis B. New-onset treatment-dependent diabetes mellitus and hyperlipidemia associated with atypical antipsychotic use in older adults without schizophrenia or bipolar disorder. J Am Geriatr Soc. 2012 Mar;60(3):474-79.

Erickson SC, Le L, Zakharyan A, Stockl KM, Solow BK, Harada ASM, Ramsey SD. Clinical and pharmacy utilization outcomes with brand to generic antiepileptic utilization in patients with epilepsy. Epilepsia. 2011;52:1365-71.

Erickson SC, Le L, Zakharyan A, Stockl KM, Solow B, Harada ASM, Ramsey SD. Clinical and pharmacy utilization outcomes with brand to generic antiepileptic utilization in patients with epilepsy. ISPOR 15th Annual International Meeting, Atlanta, GA, May 15-19, 2010.

Erickson SC, Le L, Zakharyan A, Stockl KM, Harada ASM, Borson S, Ramsey S, Curtis B. Metabolic outcomes associated with off-label atypical antipsychotic use in the elderly. American Geriatric Society Annual Meeting, Orlando, FL, May 12-15, 2010.

Pham N, Le L, Stockl KM, Solow BK, Curtis B, Lew HC, Shin J. Prevalence of inappropriate use, polypharmacy, and non-adherence with antipsychotic medications. AMCP 22nd Annual Meeting and Showcase, San Diego, CA, April 7-10, 2010.

Stockl KM, Le L, Zakharyan A, Harada ASM, Solow BK, Addiego J, Ramsey SD. Risk of Re-hospitalization for Patients Using Clopidogrel with a Proton Pump Inhibitor. Arch Intern Med. 2010 Apr 26;170(8):704-10.

Stockl KM, Le L, Zhang S, Harada SM. Clinical and economic outcomes associated with potentially inappropriate prescribing in the elderly. Am J Manag Care. 2010;16(1):e1-e10.

Stockl KM, Le L, Zakharyan A, Harada ASM, Solow BK, Addiego J, Ramsey SD. Risk of rehospitalization for patients using clopidogrel with a proton pump inhibitor. AHA Annual Meeting, Orlando, FL, November 14-18, 2009.

Stockl KM, Le L, Zhang S, Harada ASM, Solow BK, Ramsey SD. Cardiovascular outcomes for patients treated with ezetimibe/simvastatin combination compared with simvastatin or atorvastatin alone. AHA Annual Meeting, Orlando, FL, November 14-18, 2009.

Vu M, Le L, Stockl KM. Risk of rhabdomyolysis or serious myopathy among patients with statin-related drug interactions. AMCP 21st Annual Meeting & Showcase, Orlando, FL, April 15-18, 2009.

Stockl KM, Le L, Zhang S, Harada SM. Risk of acute myocardial infarction in patients taking thiazolidinediones or other antidiabetic medications. Pharmacoepidemiol Drug Saf. 2009 Feb;18(2):166-74.

Stockl KM, Le L, Harada ASM, Zhang S. Use of controller medications in patients initiated on a long-acting β-2 adrenergic agonists before and after safety alerts. American J Health-Syst Pharm. 2008;65:1533-38.

Tran T, Le L, Hong J, Harada ASM, Stockl KM. Effect of a provider-targeted intervention on occurrence of “drugs to be avoided in the elderly”. AMCP 19th Annual Meeting & Showcase, San Diego, CA, April 11, 2007.



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