Nth analytics - mike todd.doc

President of Nth Analytics, a deliberately small CRO providing high-quality statistical analysis and reporting services to the pharmaceutical industry. SAS and pharmaceutical business expert with many years experience, specializing in electronic submission support. Added Oracle and Java skillset in 2000 for advanced Internet applications (see Technical Training below). Visit www.nthanalytics.com for detailed information. DBA, Java, PL/SQL, IAS/OAS, PL/SQL Web Toolkit Base, Macro, SQL, Stat, Graph, Reporting (Data _Null_, Report, Tabulate, RTF) HTML, XML, Microsoft Frontpage, Abode Illustrator and Photoshop Operating Systems Windows 2000 Server, Windows NT, UNIX, VMS Consulting In 2002, led Nth Analytics team in design, deployment, and training for the Automated Data Definition Tool (ADDT) that automated creation of FDA-mandated Define.PDF documentation for Item 11 SAS Transport files. The ADDT was designed and validated under Merck SOPs covering system development, and passed Merck quality audit prior to Merck-wide deployment . Project leader for vaccine programming, at one time managing as many as 20 projects. Responsible for streamlining and enhancement of existing mainframe SAS programs, as well as development of new programs with capabilities of client-server based systems. Used SAS macros extensively to consolidate code across the various vaccine projects. In 1994, pulled together 15 years of detailed Varicella data in various formats for FDA medical reviewer as directed by Merck upper management. This effort, completed in 10-day period, enabled the medical reviewer to resolve the last remaining issues regarding the Varicella vaccine and led directly to FDA approval in 1995. SAS Transport Task Force As department representative to Merck-wide SAS Transport Task Force, helped determine ways to standardize SAS Transport files across therapeutic areas to be submitted in lieu of Item 11 CRTs per FDA Electronic Submissions Guidance (effective 1 August, 1999). As department technical lead, designed new programs to create SAS Transport files per new requirements and wrote SOP for SAS Transport file validation. Clinical Project Leader Supervised programmers, designed and implemented reporting programs for several Merck compounds, including Pepcid (heartburn), Cozaar/Hyzaar (opthalmics), as well as anti-hypertensive and anti-infective compounds. Often named to project leadership to meet critical timelines or to resolve quality issues regarding SAS programming. Mike Todd
As project statistician, responsible for statistical activities for large-sale clinical trials. Write statistical analysis plans and programming specifications, perform statistical analyses, validate analysis datasets and statistical analyses, review clinical trial reports, represent biostatistics at cross-functional meetings. As part of internal project team, responsible for communicating expectations to the CROs with regard to statistical and programming issues, reviewing CRO quality control (QC) processes to determine adequately of validation, and reviewing time and cost estimates. From an FDA reviewer perspective, audited SAS Transport files for a flu vaccine to ensure compliance with FDA Guidance. Verified that the files accurately supported the integrated clinical and statistical reports. Assignment required in-depth knowledge of the FDA Guidance and vaccine requirements. Statistical analysis and reports for Provigil (wakefulness-promoting agent) with tables and listings programs for mid-size pharmaceutical company with aggressive timelines. Success in this assignment depended on well-designed analysis datasets doubling as FDA Guidance-compliance SAS Transport files, as well as bullet-proof SAS analysis and reporting macros, guaranteeing consistency across hundreds of tables. Statistical analysis, tables and listings in SAS for consumer dental product in support of management go/no go decision. Statistical report, tables and listings programming for migraine compound, under tight timelines for small pharmaceutical company. Programming for acute coronary care survey in support of European marketing application for anti-coagulant compound. Statistical analysis of drug stability data. Used Statistica for graphics and SAS for analyses. Resulting graphs and tables were linked to Microsoft Word documents through OLE. Wrote NDA summary programs and created standard databases for ABELCET (antifungal compound). Mike Todd

Project leader for osteoporosis project (Proctor & Gamble Pharmaceuticals) comprised of several large and complex protocols. Responsible for project organization, upgrading quality of SAS programs and implementing improved validation procedures. CANDA Support (1994-1996) CANDA preparation included streamlining the “paper NDA” SAS programs and data sets to run efficiently on a CANDA PC, given the under-powered (by today’s standards) machines then available. Many programs required extensive revisions to complete in a reasonable amount of time. Also wrote all NDA programs for a projects involving complex designs and time-dependent dosing schedules. The same programs produced user-defined subset analyses, protocol-level results as well as NDA summaries, ensuring consistency across results sets. Also wrote SAS macro-based reporting and graphics systems under Unix. Includes design, coding and documentation. Statistical Reports (1992-1994) Statistical analysis and reports for hypertension trials. Quality assurance of clinical trial reports. Validated work of programming staff. SAS Programming (1991) Wrote SAS reporting macros and detailed user manuals and documentation. Analysis of an AIDS compound for an FDA presentation. Used SAS to write to Excel spreadsheets embedded in PowerPoint slides. Data management, including 100% data entry verification, consistency checks and protocol violations. Quality assurance of clinical trial reports. Statistical programming for MONISTAT. Standardized the SAS adverse experience reporting programs. Designed and implemented CRF tracking and budget management system using Paradox 3.5. Wrote efficacy and protocol-violation reporting systems using DCL and Version 6.06 SAS, including PROC SQL. Created standard data bases and wrote an automated documentation system for data base programming Responsible for automated statistical reporting to handle large volume of projects to enable reporting-on-demand necessitated by extremely tight deadlines that this CRO faced. The system was SAS-based with REXX components. Supervised two programmers on this project. Also wrote an SOP for version control and archiving. Senior Biostatistician (1983-1984, 1986-1987) In the demanding CRO environment, wrote many integrated clinical/statistical reports for anti-hypertensive, cholesterol-lowering, psychotropic, cancer and dental pain compounds. Supervised programmers in report preparation. Quality audits of tables and listings. Designed and implemented a VAX-based pharmacokinetic system using SIR, DCL, SAS (macro, STAT, BASE and GRAPH) and FORTRAN. Wrote an SOP for software validation. Mike Todd

Prepared statistical reports (anti-hypertensive, anti-coagulent and psychotropic compounds) for FDA submission. Wrote standard macro library for department-wide applications. Medical Programmer / Analyst (1981-1983) As project leader, supervised programmers in table and listing preparation for dermatological and psychotropic compounds. Wrote several SAS macros to implement statistical tests not then available in SAS/STAT. Technical Training Oracle DBA (1999-2000) § Introduction to Oracle for Experienced SQL Users § Enterprise DBA Part 1A: Architecture and Administration § Enterprise DBA Part 1B: Backup and Recovery Oracle PL/SQL Programming (2000): § Develop PL/SQL Program Units § Advanced PL/SQL § Oracle 8i: SQL Statement Tuning Workshop Oracle Java, OAS/IAS and Web-based Applications (2000) § Oracle Application Server 4.0.8: Administration § Oracle Application Server 4.0.8: Develop Web-based Applications with PL/SQL § Java Programming § Object-Oriented Analysis and Design Using UML § Develop Database Applications with Java – Part 1 § Develop Database Applications with Java – Part 2 § Develop Applications with Enterprise Java Beans § Create Dynamic Web Content with Java Michael J. Todd and Kathleen Dooley, A Performance Evaluation of Two Techniques for Many-to-Many Merges, Observations (SAS Technical Journal), 4th Quarter, 1994. Michael J. Todd, Roger Landau, Theodore Koziol, Robert Dwyer and Kim Nitahara (1987), Validation of the Bioanalytical Computer System, Drug Information Journal, Volume 21, Number 4. Michael J. Todd (1985), Macro Power: A Procedure to Generate Wilcoxon Rank Sum Power Curves, Proceedings of the Tenth Annual SUGI Conference, SAS Institute, Inc., Cary, NC. Mike Todd

Electronic In-Text Table Production at Merck & Co., Inc. (with David Manfredonia and Margaret Coughlin), DIA Worldwide Issues and Solutions for Clinical Data Management, Philadelphia, Pa., March 8, 1994. A Performance Evaluation of Two Techniques for Many-to-Many Merges (with Kathleen Dooley), Philadelphia SAS Users Group Meeting (PhilaSUG), West Point, Pa., February 17, 1994. Automatic In-Text Table Production at Merck & Co (with David Manfredonia). Northeast SAS Users Group (NESUG), Springfield, Massachusetts, 1993. Validation of the Bioanalytical System At Berlex (with Roger Landau). Drug Information Association Workshop on Computer Software, System, and Data Validation, Philadelphia PA, 1986. Automated Reporting Methods - Statistical Reporting Techniques. Drug Information Association Workshop on "Clinical Data Management - The State of the Art", Philadelphia PA, 1985. A SAS Macro for Analyzing Tissue Residue Studies (with David A. Bennett). ENAR/ASA Spring Meeting, Raleigh NC, 1985. Macro Power: A Procedure to Generate Wilcoxon Rank Sum Power Curves Tenth Annual SUGI Conference, Reno NV, 1985. Drug Information Association (DIA). Listed under Nth Analytics in DIA CSO Directory

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