Earl H. Leonard III, Principal Biostatistician

TECHNICAL SKILLS:

Biostatistics, Statistical SAS Programming, and data consulting,

NCQA HEDIS, CMS CAHPS and HOS metric reporting and analysis

Medi Cal, Medicare Advantage (D SNP), Ryan White, ADAP reporting and analysis,

Provider Satisfaction Survey design, project management (P&P, Desktop Procedures),

Executive reporting, Health Plan Intervention and Program Evaluation

Analytical support for Care Management,

SAS Clinical Data Automation, Production Programming, Advanced Data Analytics, Priority Matrices,

Regression Modeling, SUG

Epidemiological & Behavioral Research, and HIV/AIDS

Sample Size Estimation, Sample Frame selection and Validation, Power Estimation

Clinical Reporting & Statistical Analysis Planning (SAP),

Project Management, Milestones, Risk Mitigation, Dependencies, Issues, Actions

Clinical Research & Clinical Trial: Pre Clinical, and Phase I IV

FDA, CDC, and NIH correspondence and reporting of metrics, SOP’s, CRF’s design

ISS, ISE, ANSI, ICD 9, CE Mark, ICH-GSP, 21 CFR Part 11, CLS, ANSI, CDISC, ISO, and MIOL Standards

HEOR, AMCP, OMOP CDM, EMR and EHR, Medicare Claims, and 3M Grouper (DRG)

WSOPs/Guidelines/System Life Cycle methodologies

SUMMARY OF QUALIFICATIONS

Team thinker providing statistical programming, sample size estimation, power calculations, data imputation, data processing and manipulation, weighting, program validation, and report automation.

20+ year experience providing statistical programming support for study design, analysis database design, and database management support for clinical trials (ISS, ISE, CE Mark), clinical research, TLG, and reporting.

10+ years’ experience providing survey study design, management of vendors, timelines, and analysis planning.

5+ years managing statistical consulting and data analytic team.

12 years’ experience with ICD 9, 2 year ICD-10.

3 years’ experience with HEDIS measures in a 5 Star health plan with 3.5 million covered lives in southern California.

6 years’ experience with HEDIS and CAHPS measures in the Nation’s largest publicly operated health plan.

15 years of experience with Clinical Research – Pre clinical, Phases I IV.

9 years of experience with HIV/AIDS research and evaluation.

6 years of oncology clinical trial analysis experience.

SOFTWARE EXPERIENCE

20+ years of experience as a SAS Statistical Programmer (SAS/Base/STAT/Macro/SQL/Graph/EG 5.1- 7.1/Enterprise Miner); SAS Grid 9.4 Office Analytics, BI Server, Access, and Oracle (SQL).

R, NCSS, PASS, SOLAS for Missing Data, BMDP, SPSS, and STATA.

Quest Software: Toad (T) Data Modeler 3.4, T for Analyst, T for Oracle 12.1.

EDC Teleforms, RDC PDF+ Forms, and ABBYY Flexi-Capture.

MS Office, Tableau, ODBC, HL7, BRIDG, and XML.

PROFESSIONAL EXPERIENCE:

Alphanumeric Data Consultants Jun 2017 – Current

Principal Biostatistician/Director of Biostatpal

Direct biostatistics activities for clinical studies from trial design, execution, analysis, and data interpretation. Serve as the subject expert for the therapeutic area and provide leadership to support all clinical studies, regulatory submissions, and publications for the product in charge. Serves as biostatistics lead for one or more clinical programs. Coordinate with data management and statistical programming on activities related to all program clinical studies.

Train clinical trial programming staff with setup and management of electronic data capture systems.

Play a key role in the development of biostatistics processes and procedures, including the writing and review of department standard operating procedures.

Participate in the development of clinical study protocols, including experimental design, specification of analysis endpoints, determination of sample size, and specification of methods of statistical analysis.

Participate in the design of case report forms and reviews data validation specifications and other data management documentation associated with clinical study database development.

Develop, review, and approve statistical analysis plans. Researches, develops, and implements statistical methods appropriate to clinical study design and objectives and consistent with current regulatory standards and requirements.

Design the layout and content of tables, figures, and listings in accordance with statistical analysis plans.

Review clinical study reports. Ensures that statistical methods are appropriately documented in clinical study reports and that study results and conclusions accurately reflect the statistical analyses.

Participate in regulatory submission planning, including data submission strategies and the creation of integrated summaries. Develops and reviews statistical analysis plans for integrated summaries of safety and efficacy.

Kaiser Permanente: SAS Developer, All Drug Model.

LA Care Health Plan Apr 2011 April 2017

Senior Biostatistician, Health Outcomes and Analysis

Provide biostatistics consultation to HEDIS team, QI, PNO, Member Services, Pharmacy, and various service provider groups within the L.A. Care network.

Operate as lead statistician for the Provider Satisfaction, Access to Care, and Care Management Patient Satisfaction Survey studies.

Provide risk mitigation, monitor milestones, dependencies, issues, critical paths, Gantt Charts, and take action.

Create policies and desktop procedures documents according to Regulatory Affairs Compliance specifications.

Provide advance analytics including predictive modeling, priority matrices, regression modeling for provider group (PCP, SCP, Clinic, PPG, Ancillary, Hospital), and member level studies.

Write RFP’s and consult with vendors for survey sampling design and methodology, and cost.

Manage and reported to California State Department of Health Services, L.A. Care Utilization Management Committee (UM) and monitor provider and member participation in survey studies.

Generate clinical studies and analysis datasets according to regulatory agency requirements.

Presented briefings to UM, Services Improvement Committee (SCI), Compliance and Quality Improvement Committee, and at the APHA Annual Meetings. Performed intakes for new studies and evaluated interventions.

Serve as a subject matter expert to internal and external clients regarding hospital readmission and risk adjustment of Medi Cal and Medicare rates using NCQA model and 3M Grouper DRG.

Provide OMOP Common Data Model analysis using L.A. Care Pharmacy Claims and EHR data.

Provide recommendations for processes that improve efficiency and effectiveness.

Facilitated timely resolution of issues and implemented systematic and manual processes for clinical trials work.

Enhance overall efficiency, effectiveness and functionality of SAS systems for HO&A staff.

Follow ICH and CDISC programming guideline using SAS software.

Ensured the integrity of data used for reporting, using validation and cross validation techniques, data verification, and information update.

Led projects and worked with internal and external staff for support.

Researched and recommended vendor choices for projects by evaluating proposals, making recommendations to the scope of work.

Set time lines to comply with regulatory and accreditation requirements, and monitored vendor activities throughout contract period.

Managed project budgets and the budget approval process for the Provider Satisfaction Survey and Access to Care. Validated sampling frames for Provider Satisfaction, Access to Care, and Medicare CAHPS surveys.

Assisted in writing of executive final reports and memorandums to the Chief Medical Officer.

Briefed findings to HO&A team, departments within the L.A. Care Health Plan, Board of Directors, and various committees.

Published abstracts (APHA), and presented findings at national conferences, in newsletters, and articles for both internal and external sources.

Alphanumeric Data Consultants Nov 2008 – Mar 2010

Principal Biostatistician

Charles R. Drew University of Medicine and Science, Los Angeles, CA

Biostatistics Consultant (Contractor)

Used a 3 stage cross sectional sampling technique to randomly intercept, screen, and interview African American smokers residing in Los Angeles County.

Study the social and cultural effects of menthol smoking in African Americans.

Used frequency distributions, means, and cross tab procedures to describe the sample.

Performed chi square test, odds ratios, analysis of variance, and used Tukey’s post hoc procedure to compare Menthol, Non Menthol, and combined smoking groups.

Performed Cronbach’s alphas, factor analyses, and multinomial logit modeling in SAS to evaluate the independent effects of each attitudinal, social, and cultural outcome on smoking groups.

Performed multiple regression analyses.

AcuFocus, Inc. (Department of Clinical Regulatory Affairs), Irvine, CA

Senior Biostatistician (Employee) Mar 2008 – Nov 2008

Reported directly to the Vice President of Clinical Regulatory Affairs. Collaborated with the VP and

Director of Clinical/Regulatory concerning interpretation of results and methods for improving Kamra

products.

Prepared patient and physician randomizations for Phase II clinical trial of Acufocus Corneal Inlay (ACI) in presbyopia subjects (Protocol ACU P08 020).

Contributed to writing and review of clinical reports, CE Mark, and FDA submittals.

Estimated sample size for a prospective multi center clinical trial to evaluate the safety and effectiveness of the Acufocus Corneal Inlay (ACI) in presbyopic subjects (Protocol ACU P08 020). Utilized ANSI Standards (Z80.11 2007) to estimate sample size based on safety estimates and effectiveness estimates using non inferiority hypothesis testing, contrast sensitivity, and endothelial cell density.

Estimated sample size for an Inter Observer Manifest Refraction and CE Mark studies.

Monitor actual study power at each follow up point in trials. Responded to FDA deficiency claims in Pre

IDE and IDE submittals and progress reports.

Design data collection programs for multiple clinical study protocols using Microsoft Access/SQL (Istanbul, Inter Observer, Thin, and Pocket studies).

Automate weekly clinical reports for ACI 7000 Phase II, Istanbul, and Pocket studies using SAS/MACROS/Proc Reports.

A typical clinical report includes subject VA outcomes (postoperative to preoperative data comparison), by site

and physician at each follow up point (DCDVA, DCNVA, BCDVA, UCNVA, & UCDVA).

Created study data tabulation model (SDTM) and Analysis Data Model Subject Level (ADSL) SAS datasets

for Phase II investigational device exemption (IDE) Clinical Protocol ACU P08 020, ACU Focus Corneal

Inlay (ACI) 7000 PDT.

Created electronic common technical documentation (eCRT) using MS Office Word.

Created Analysis Data Model Time to Event (ADaMTTE) SAS datasets within Basic Data Structure (BDS).

Generated tables, listings, and graphs using SAS. Monitored study power throughout duration of the study.

Monitored key efficacy and safety variables over trial study periods using SAS.

Applied TTE analysis methods such as Kaplan Meier’s product moment curve, log rank tests (stratified over study period), Wilcoxon tests, and cox proportional hazards model on time to adverse events. Present the

most powerful results.

Estimate subject variability for outcome measures over trial and compared subject estimates with group

Estimate, and subject variability with group variability, at each time point.

Compared sub group variability with overall group variability to identify lesser performing sites/physicians.

Conduct interim analysis of ACI 7000 Phase II data, Istanbul Study, and other clinical Studies.

Used a Doubly Multivariate repeated measures design to perform multivariate tests for time and treatment main effects, as well as their interactions, across outcome Measures.

Performed extensive repeated measures analyses on Central and Limbal Intraocular pressure change, manifest refraction, contrast sensitivity, and endothelial cell density across study time points.

Validated SAS data processing programs.

Consulted to manufacturing department regarding protocol validation: IQ, OQ, PQ & PPQ. Risk Benefit Analysis: Used adverse event results from ACI Phase II study to determine risk for a new ACI 7000 PDT.

Supervised data entry staff for Phase 0 studies.

Design data entry programs using Access. Trainings: FDA 21 CFR Part 11 Compliance, HIPAA, and KOLBE.

Kaiser Permanente (Department of Clinical Analysis), Pasadena, CA.

Data Consultant Oct 2005 Feb 2008

Produced periodical and annual reports for Health Plan Employer Data and Information Set (HEDIS) 2007

performance measures, which included: Prenatal and Postpartum Care, Appropriate Testing for Children

with Pharyngitis, and Appropriate Testing for Children with Upper Respiratory Infection, using SAS

Mainframe and PC systems.

Extracted data from KPSC Source Systems/Databases.

Data systems include Clinical Appointment Request System Registration, Laboratory Management System/Results Management System, Encounter Coding System, Outside Claims Processing System, Outpatient

Appointment System, Inpatient Data Abstract System, Pharmacy Information Management System,

Perinatal Services System, and the Common Provider Master system; these reports compile data

collected from Kaiser’s SOCAL 3.5 million eligible patients Population.

Processed reports on a bi monthly and annually basis to include administrative and commercial Medicaid/Medicare customer frequencies and rates.

Responded to annual audits for selected care providers.

Generated hybrid random samples for various measures to verify data quality.

Contributed to validation of other users SAS programs.

Produced ad hoc reports for population Care Management. Estimated bi annual Polypectomy rate for a

study of Colonoscopy patients seen between 1999 and 2005.

SAS programmer for the ‘In Reach Referrals and Missed Opportunities Report’ This periodic report illustrates the percentage of “Missed Opportunities” for successful referral of female members due for breast cancer screening, Chlamydia screening and Chlamydia screening at time of Pap test.

Furthermore, frequency and percentage of successful referral for both male and female members due for Diabetic Hemoglobin A1C Testing, Diabetic Cholesterol (LDL C) screening, Diabetic Nephropathy Monitoring (Microalbumin), and Follow up for High Blood Pressure are reported.

Composite Score is computed for all measures’ missed opportunity percentages.

Managed and completed adhoc reports requested by Medical Center and Department

Integrated data across Microsoft SQL, SAS Mainframe, and Clarity databases using SAS BI Server platform and generated reports for production purposes.

Los Angeles County Office of AIDS Programs and Policy, Los Angeles, CA,

Associated Software Consultants (CRO)

SAS Statistical Consultant Apr 2000 Oct 2005

Provided support for research hypotheses directed towards improving Los County HIV Prevention programs, Ryan White CARE Act services (funded by the State of California and Center for Disease Control (CDC), and the Health Resources and Services Administration (HRSA), respectively.

Served as a SAS subject matter expert to the Research and Evaluation Department. Provided statistical support for evaluating the feasibility, effectiveness and acceptability, of incorporating HIV/AIDS Information Technology Systems (HITS) into existing HIV/AIDS care services and HIV counseling and testing (HCT) infrastructure.

Supervised data entry staff and designed data entry processes.

Analyzed focus group data, pre and post HITS, provider survey, and client level questionnaires.

Conducted a multivariate analyses of Core Service category measures for the Ryan White CARE Act Title I project.

Marginally normalized measures using a natural log transformation.

Performed correlation analysis of transformed data, controlling for client demographics, and special needs populations.

Identified service categories that were best modeled independently, versus those with multivariate techniques.

Contrasted differences within control variables using the best multivariate or univariate model. Wrote up results and developed hypothesis for testing the effects of implementing HITS in publicly funded HIV/AIDS organizations providing HCT and HIV/AIDS patient care services within Los Angeles County.

Designed statistical models for testing the efficacy of HITS. Estimated sample size and power of statistical tests.

Presented findings at the SPNS IT Initiative Annual Meeting .

Proved that linking HIV/AIDS medical inpatient/outpatient service providers to a centralized database improved

patient services utilization and care.

Compared medical outpatient service outcomes pre and post implementation of HITS. Statistical tests performed included, Odd Ratios (Homogeneity and Heterogeneity), Mantel Haenszel, Trend tests, t Tests, and Chi square tests.

Produced Tables/Listings/Graphs and QC programs for other programmers. Analyzed and published findings from the Los Angeles County Follow back Survey, 2000.

Statistically tested research Hypotheses using SAS and Sudan. Conducted weighted data analysis of a population based random digit telephone survey of HIV risk behaviors, access to HIV care services, and awareness of HIV prevention strategies.

Statistical test include Cochran Mantel Haenszel Chi square, odds ratios, and descriptive statistics.

Wrote SAS macro programs to interfaces with MS Access SQL Server databases (CARE and HIRS), deduplicate

and warehouse counseling and testing, and IMAC/Case Watch qualitative and quantitative client level data sources.

Generated front end reports for the departments of Planning and Research, Public Affairs, and Information System purposes.

Managed data processing procedures that make use of high speed Computers.

Provided SAS support and consultation to Information Systems (personnel/consultants) and vendors.

Collaborated on writing and reviewing SOPs, writing statistical analysis plan, database transfer from vendors (ACMS), database lock and unlock, SAS program validation and documentation, SAS programming standards, network directory structure. Collaborated on writing utility macros.

Assisted Clinical Operations department in CRA training, CRF guidelines, Statistical consulting, ad hoc requests,

and data analysis.

Interpreted statistical results for a non statistical audience. Used logistic regression models to analyze change between baseline and two year follow up in CD4 levels for Ryan White CARE Act clients, stratified by year.

Estimated and compared odds ratios by race, payer source, client behavioral risk group using EGRET Software. Prepared reports and publications based on research findings and recommendation of the Planning and Research director and senior OAPP staff.

Presented and identified data collection needs at the Data Outcomes for Primary Care Providers meeting, 2004.

Generated quarterly and annual HIV Counseling and Testing Reports, for years 1998 – 2001 data.

Orally presented findings at the annual American Public Health Association conferences.

Generated data analyses for provider and client level data request, including IMACS, ACRS, MICRS, and

SPNS data sources.

Wrote SAS Macro programs to transform and merge Los Angeles State funded HCT data and Los Angeles County CDC funded Scantron collected data into a SAS dataset.

Exported data into ASCII to be read by CDC software, processing included approximately 80,000 client level records annually.

Collaborated on writing and reviewing SOPs, writing statistical analysis plan, database transfer to vendors, database lock and unlock, SAS program validation and documentation, SAS programming standards, network directory structure.

Collaborated with Information Services on writing utility macros.

Generated statistical analyses for the Ryan White Care Act annual renewal application, 2003 2005.

Wrote and provided research design support and analysis input for abstracts and Publications. Provided the director of Planning and Research with software needs assessment (GIS, TELEforms, and ABBYY). Fit a cross sectional Poisson regression model on data for 288 HIV positive pregnant women at risk for transmitting HIV to their newborn.

Time of entry into prenatal care, medical outpatient services consumption, total number of opportunistic infections and CD4 outcomes were compared, pre/post-delivery, controlling for client demographics, social economic status, and anti retroviral therapy.

Children’s Hospital Los Angeles (Biostatistics Core), Los Angeles, CA

Senior Biostatistician Oct 1995 Mar 2004

In conjunction with Principal Investigators and faculty, developed conceptual models and research design that can be tested using advanced analytical techniques.

Assisted with planning analytical activities.

Annually presented a session on statistical software to staff and residences of Children’s Hospital, part of the annual Biostatistics course for CHLA residence.

Serviced 40 to 60 projects annually with biostatistics consultation, bio assay, data management, SAS programming, and data analytic services.

Provided users support for GCRC statistical applications Citrix farm.

Involved with the following projects at Children’s Hospital:

Bone Marrow Transplant:

Provided statistical analysis for study of interleukin 7 (IL 7), a major thymopoietic cytokine. Tested the effects of radiation on thymic reconstitution in mice irradiated with total dose of 1000, 1200, or 1400 cGy and a non irradiated normal control group (Pre clinical). Generated two tailed t Test results for pairwise comparisons.

Radiology Oncology Program

Compared P300 Latency results from Mirsky, Polch, and Sato et. al. Tested the effect of higher P300 Latency over age. Fit a multiple linear regression model. Plotted regression curves. Estimated sample size for a Phase III clinical trial of P300 Latency. Reviewed clinical protocol, Case Report Forms (CRFs), and CRF instructions.

Hematology Oncology:

Designed CRF and managed data for a sickle cell disease study with TELEforms software, a five thousand record database contained client level data on patients living with sickle cell disease. Electronic CRFs were entered by physicians and attendees into PDF+ electronic forms. Phase III Clinical trial of Actin and Fgfr2. Imputed missing data using predictive model based multiple imputation methods with Solas for Missing Data software. Each subject received 3 treatments in random order Subjects were classified as male and female. General linear models were used to test for treatment, sex, and treatment by sex effects. A mixed model analysis of variance was performed to create mixed parameters and mixed

covariance B datasets. Mixed parameter matrix and mixed Covariance B matrices were printed using “Proc Print”. “Proc Mi Analyze” was used to provide combined estimates of mixed parameters and covariance B matrices.

Opthamology:

Phase I trial of LD50 for Retinal Toxicity in Rabbits: Estimated LD50 and its 95% Confidence Interval using various Logistic Regression methods. Applied a log (dose) transformation and compared confidence intervals, Added a quadratic term in search of a better estimate. Compared results of probit analysis on log(dose) which yielded similar results for LD50, but wider confidence intervals than logistic regression method. Estimated sample size for Phase II Optic Nerve Hypoplasia Study (ONH). Designed EDC patient Medical, Neuropsychological, Neurological, Neuroradiographics findings, Growth Hormone Stimulation Test, Electrophysiology, Fundus Photos, Endocrinology treatment, testing, and exam findings forms

using TELEforms PDF+ forms. Analyzed the Neuropsychological data using t Tests Graphed mean results using sigma plot.

Pediatrics:

Estimated the sample size required to assess the safety, efficacy, and cost effectiveness of rapid nasogastric hydration (RNG) and rapid intravenous hydration (RIV) administered in the emergency department to pediatric patients suffering with uncomplicated, acute Moderate dehydration. Compared electrolytes, blood urea nitrogen, creatinine, and glucose levels at baseline and at the end of treatment using t Tests. Applied repeated measures ANOVA to these levels. Compared the relative improvement in C02 after therapy using chi square, and graphed result.

Biostatistics Core:

Designed an EDC biostatistical client management system with Web enabled forms for the purpose of managing the daily biostatistical consulting activities of the Biostatistics Core. Forms were designed in TELEforms, PDF+ forms and back ended with a MS Access database. Created client billing reports and biostatistical work performance reports to better monitor client consulting processes and organize staff. Provided annual presentations on biostatistical software and basic biostatistics for residents and staff at CHLA.

Independent Consultant, Los Angeles, CA

Senior Biostatistician (Contractor) Jun 1991 Oct 1995

Provided biostatistics consultation, clinical database management, and research design and analysis support for contracted studies.

Supervised data entry staff and assistant biostatistician.

Projects were contracted through Charles R. Drew University of Medicine and Science, Divisions of Family Medicine, and Department of Cancer Consortium, SHIELDS for Families Projects.

Other studies were contracted through Dollarhide Health Center, California Women’s Commission on Addiction, Joint Efforts Inc., and USC School of Medicine.

Supervised data analyst and data entry staff and managed the consulting business.

Submitted bids for RFPs requiring statistical analyses and data management support.

Charles R. Drew University of Medicine and Science Sep 1986 Jun 1991

Department of Community Medicine

Senior Biostatistician

Designed data input protocol for research surveys using dBase III PLUS for the King/Drew Smoking Cessation Study (system was later upgraded to dBase IV).

Wrote SAS data cleaning and screening programs, and collaborated with research assistances to correct data entry errors. Wrote dBase and SAS programs to generate weekly reports for telephone interviews conducted by California Survey Research (CSR).

Monitored patient follow up and physician counseling intervention. Computed descriptive statistics and preliminarily tested all related hypothesis for quarterly reports, site visits, and presentations.

Performed a one sided test for equality of proportions in a Treatment and Control group.

Wrote MICROSOFT C programs to estimate sample size and power for the binomial distribution.

Monitored power of the test statistic. Used Logistic Regression (BMDP LR) to fit models for odds ratios.

Performed repeated measures ANOVA on smoking quantity and smoking cessation at baseline, 3

months, and six months follow up. Provided statistical consultation for evaluation of a cervical cancer

prevention project in South Central Los Angeles. Analyzed focus group data.

Estimated power and

sample size to conduct a Cervical Cancer study on minority women. Statistical procedures include Chi square, t Test, Analysis of Variance, Logistic Regression (Odds Ratios), Wilcoxon Rank Sum Test, and multiple samples Kruskal Wallis Test. Provided statistical consultation for abstracts and research papers.

Department of Neuroscience and Epilepsy

Biostatistician/SAS Programmer

Designed data input and verification protocols using KEYENTRY III for a study of Pharmacologic Prophylaxis of Post Traumatic Epilepsy (PTE) and a program project of Clinical and Epidemiological Studies of Human Epilepsy (SHE), funded by NIH NIHNDS.

Wrote SAS file transfer programs along with data quality control routines.

Collaborated with research staff to ensure correctness and validity of data.

Reviewed case report form (CRF), design drafts based on protocol stipulations.

Active member of the CRF development team. Created CRF completion guidelines based on protocol stipulations.

Attended protocol initiation and/or investigator meetings and communicated with sponsors and in house monitors.

Wrote data edit specifications in preparation for programming by programmers receiving

CRFs and maintaining data management track logs to follow CRF progress through the system.

Thoroughly reviewed CRFs for clinical accuracy and quality assurance with team monitors.

Performed sample size estimation for a double blind clinical trial of Dilantin and Phenobarbital.

Monitored rates of seizure and adverse events among treatment and control groups.

EDUCATION

1985 1987: M.S., Biostatistics, University of California, Los Angeles, California

1979 1984: B.S., Mathematics, University of California, Irvine, California

ASSOCIATIONS/HONORS

APHA 2004: Awarded first place among new authors

American Statistical Association

PUBLICATIONS/ABSTRACTS:

(List of Publications Available Upon Request)

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