Lynn Kivell Ashcraft

PROFESSIONAL

PROFILE:

Experience delivering analytical information solutions including: Post Marketing and Competitive Analysis, Health Risk Analysis, Formulary Placement, Disease Management, Intervention Design, and Clinical program support from pre-clinical through Phase IV, 21 CFR Part11 Validation, Labeling Analysis, AE Signaling, and Statistical Analysis of clinical trial data, health economic and QOL data across multiple therapeutic areas including CVM, Oncology, and Neuroscience.

Results-oriented, problem solving, team motivating professional able to orchestrate the practical application of technology to create meaningful business intelligence within a validated environment.

Areas of Expertise:

Outcomes Research Human Factors

Health Risk Management Training

Standards Development Project Mgmt

Web portal design Validation

Statistical Programming Database Programming

Data Mapping Label Analysis

Market Analytics QC/QA AE Signal Analysis

Business Process Reengineering

Experience: Assignments include:

· Creation of a standard patient profile for Phase IV Clinical Trials at an initial cost savings of $250,0000

Developing health risk models utilizing both self-reported and health care claims data for a Disease Management Group. Tasks included: performing cohort studies using epidemiological analysis techniques such as 2x2s, odds ratios, relative risk calculation, and logistic regression to demonstrate to employers the relationship between their employee’s health behaviors and their health risks.

· Creation of a State of the Health of the Workforce Overview for Employers and Insurers, including a snapshot Executive Briefing utilizing graphics and traffic lighting techniques to keep messages short and on target.

· For a company group tasked with delivering patient interventions, performed a technology assessment for upper management including a final assessment report with both tactical suggestions for improving delivery of current services as well as suggestions for how to migrate to a more robust platform that would support future growth of the business.

· Collaborated with business specialists, clinical writers, medical personnel, computer services developers and infrastructure personnel, to provide reports key to the company Medical Safety Area responses to the FDA, EMEA and French Drug Authorities. Over 50 validated reports, including, PSURs, Benefit/Risk Analysis, Serious and Non-Serious AE Listings, Prevalence Reports on Fatal and Non-Fatal AEs, and Signaling Analyses were produced within four months with strict adherence to both company SOPs and ICH guidelines.

· Responsible delivery of a plug-in module for PROVANTIS used to generating normal ranges from the data collected in a toxicology laboratory. Duties included: management of a development team based in the UK and insuring that the module passed 21 CFR Part11 validation.

· Responsible for development of the first electronic computer system for data scrubbing of CRF data according to ICH guidelines at a medical device company. The module used to check overall CRF completion, developed through dialogs with clinicians and statisticians shortened the time to study database lock by allowing early detection of data anomalies, enabling clinical teams to coach investigators on how to fill out the CRFs better. The methodology behind this module became an SOP for data quality.

· Responsible for the timely delivery of reports and the selection of statistical analyses to be used by marketing for strategic and tactical planning as well to track the progress of current business initiatives. Deliverables ranged from EXCEL spreadsheets and ACCESS databases to large data extracts to be used by outside vendors. Data analyzed included: call data, physician targeting data, product marketing definitions, and weekly and monthly sales .Tools used included: Business Objects, DB2, SAS Mainframe, HPUX, and PC platforms, FTP,ACCESS, EXCEL.

· For an application to manage business rules, conducted JAD sessions to uncover undocumented business rules and processes; authored the initial draft design document; conducted the initial document review; developed the list of revisions to be made based on the review, and provided project management with an initial timeline and project plan for developing the application.

· Responsible for implementing the software inspection program as part of an initial effort to utilize quality assurance techniques. Developed inspection guidelines covering types of material to be inspected, composition of inspection teams, definition of error classes, and criteria for passing inspection, as well as scheduling project inspections and collecting and tabulating inspection report statistics. A training curriculum along with the supporting budget materials was created and delivered as part of the program roll-out.

· Had total responsibility for implementing the ETL process to generate the load files necessary to create an EXPRESS cube to analyze sales data at the zip and territory level. The cube was created as a prototype for an enterprise wide data warehousing initiative. The load files created included those for both dimension and fact data. The backend was written in SAS, including the MACRO language, running on an HPUX server accessed via EXCEED. The process was automated via UNIX Shell scripts scheduled via Chron utilizing FTP as a data transport mechanism. The warehouse was over 2 terabyes in size.

Novartis Projects since March 2006

· Exploratory Analyses including survival and other time to event analyses for CV, Diabetes, Oncology, and Neuroscience portfolios

· Dose/Response Exploratory Analyses for Lotrel, Diovan, and Starlix

· Created ad hoc reports with statisticians in response to Global Group Filings

· Phase IV safety and efficacy analyses for:, Starlix US07, Diovan US02, US04, US05,US06,US07, US52, US70 , Lotrel US12, US19, Stalevo US11, Elidel US09, Focalin US08,US09,US12,US13,US16, pooled analyses, Exelon US38, Stalevo US11,RAD201, RAD251, Aliskiren CSPP100AUS02, Zometa, GleevecUS177, Exforge US01

· Galvus Global Trial A23119

· Created raw and derived study datasets, wrote edit and verification checks for database lock

· Types of multicenter clinical trials included: Double blinded, Open-Label, Cross over/parallel group designs

· Utility to load transport files

· Utility for the Calculation of Confidence Interval for Small proportion using Fleiss’s Statistical Methods

· Patient Profile developed across NOVDD panels and datasets piloted for ELIDEL US09 DSMB and used to help Clinical team review data.

· Developed Standard Patient Profile across NOVDD CRF panels and datasets to be used to view trial data by patient across visits

· WEB(EDI) created batch load files for archiving legacy study materials- TLGs

· Presentations on analytic techniques as applied to clinical trials for both our group and Statistics Informal meeting (both as single presenter and co-author):

SAS to Windows Tips

Lessons Learned Using the Gail-Simon Test for AIBL

Treatment Efficacy and Center Size

SPH100A Studies Using Bootstrap and Bayesian Approaches

to Check the Variation of Trials

· An Empirical Test for Using a Cox Proportional Hazards Model with

Time-Varying Hazard Ratios in the Analysis of Cardiac Disorders

in Hypertensive Patients
(JSM 2007 paper with Das Purkayastha as Senior author )

· Created RAMP and VAP documents, including authoring RAMP Module 8 Programming Specifications

ORACLE Clinical, Macro, PROC FREQ, PROC CORR, PROC UNIVARIATE, PROC REPORT, Data Step, ODS, Survival Analysis, Mixed Models, PROC GLM & MIXED, Boxplots, AUC, Regression and Correlation analyses, shift tables, CSR TLG preparation, WEB(edi), SAS/GRAPH, Repeated Measures, GPLOT, GCHART, IVRS

Computer Skills:

Languages: SAS, Base SAS, Macros, SASStat, GRAPH,FSP, IML, Report, SQL,ODS

V8.2 and V9, EnterpriseSAS/INTRNET, PL/SQL, SQL Plus, Ksh,

AWK,VISUAL BASIC, PERL, HTML, XML, Dataminer,

Java, NetBeans, C, CLINPLUS, VISUAL BASIC, PL/I, FORTRAN, COBOL

Stamdards: ICH, 21 CFR Part11, CDISC, HL7, HIPPA, HEDIS, NOVDD

DBMS Exponent, PlanTrak, NDC, MEDRA, ORACLE CLINICAL, CLINPLUS, ORACLE, DB2, SQLServer, ACCESS, IMS, SCOTT-LEVIN, FITCH, COMPUTSTAT, SYBASE, INFORMIX, FOCUS, RAMIS, FOXPRO

Reporting: BUSINESS OBJECTS, BRIO, MICROSTRATEGY, COGNOS, POWERBUILDER,

EXPRESS, CRYSTAL REPORTS

Operating Systems: UNIX, LINUX,MS‑DOS, OS2, WIN 98/2000/NT/XP,VISTA CMS,

MVS/XA, VM, TSO/ISPF

Tools: MS Power Point/Office/Excel, MS PROJECT, Word, WordPerfect, Adobe Acrobat

Certifications: NJ Insurance Producer’s License with Life Authority, Series 6,66

Training:

SAS : JULY 2002 Categorical Data Analysis Using Logistic Regression

MAY 2003 Predictive Modeling Using SAS Enterprise Data Miner

Attended SUGI 2002, 2003

Attended Better Business Management 2004, 2005 as invited SAS guest

O ORACLE Introduction to PL/SQL 1998

OTHER: Data Mining M2004 Conference with CEUs

Better Management Institute 2004, Health Track with CEUs

Education: Completed 2.5 years toward BA at CornellUniversity interrupted due to

family circumstances

Teaching: Prepared and delivered in-service one-day training seminar on “Using TSO ISPF, the EDITOR, JCL, and SAS”.

Awards: Received four Novartis Above and Beyond Awards in 2007-2008

One for creating the Patient Profile and saving the company over $250,000

Two for continuing support of the Patient Profile Initiative

The fourth for supporting the CVM franchise

Publications:

“An Empirical Test for Using a Cox Proportional Hazards Model with Time-Varying Hazard Ratios in the Analysis of Cardiac Disorders in Hypertensive Patients”, D. Das Purkayastha and Lynn Ashcraft in the Proceedings of the JSM for 2007.

“Initial Inspection Coordinator’s Report on Metrics for Software Quality”,

Bell Labs Technical Memorandums, 1984.

Other Clinical Experience:

6/1974 to 9/1975 - CornellUniversity

Initially worked as a histology technician and eventually became the supervisor at the NYS Vet School Diagnostic Histopathology Lab. Responsibilities included: supervising the preparation of all samples received by the lab for histological analysis by department pathologists, preparation of class sets for training Vet students, training two new histology techs, preparing slides for research projects, and creating SOPs for the lab.

Employment History:

03/2006 to present - Consultant Statistical Programmer Novartis

04/2005 to 02/2006 - Consultant Genentech

06/2004 to 10/2004 - Consultant Schering-Plough

03/2002 to 04/2004 - Biostatistician Pharmacia/Pfizer Healthcare Solutions

05/2001 to 10/2001 - Consultant Wyeth

10/200 to 03/2001 - Consultant Bristol Meyers Squibb

04/2000 to 09/2000 - Consultant Biostatistical Programmer Schering Plough

12/1999 to 05/2000 - Consultant Senior System Auditor Schering Plough

01/1999 to 12/1999 - Consultant Lead Programmer Novartis

03/1998 to 12/1998 - Consultant Warner Lambert

09/1996 to 01/1997 - Consultant Agilent

11/1989 to 06/1990 - Consultant Bristol Meyers Squibb

12/1989 to 07/1990 - Consultant BASF

07/1989 to 08/1989 - Consultant MCI

11/1988 to 09/1989 - Consultant Pfizer/Howmedica

08/1987 to 11/1988 - Consultant AT&T

06/1986 to 07/1987 - Consultant Bell Communications Research

03/1985 to 05/1986 - Consultant Bell Core HQ

01/1984 to 01/1985 - Consultant Bell Labs

05/1983 to 01/1984 - Consultant AT&T

12/1982 to 05/1983 - Consultant CONED

10/1982 to 11/1982 - Consultant Chemical Bank

04/1982 to 10/1982 - Consultant Philip Morris

11/1981 to 03/1982 - Consultant AMAX

07/1981 to 11/1981 - Consultant St. Regis Paper

10/1980 to 05/1981 - Consultant IBM

10/1975 to 07/1982 - ConsultantCornellUniversity

Ran a service bureau for university researchers. Services included: transferring data to machine readable form; including keypunch cards, and flat files; performing data conversions between mini and main frame computers; developing questionnaires and techniques for stratifying and analyzing responses; and verifying the data input efforts of others. Projects included:

Had total responsibility for project data processing for a study at the

BusinessSchool on the effects of insider trading on stock market prices.

For a study on factors affecting mobility of the work force had total responsibility for project data processing, including acting as the project liaison with various government personnel.

For a study performed for the Canadian government to determine factors affecting recidivism among the criminal population had total responsibility for project data processing.

For the NYS Department of Energy was part of a multi-disciplinary team which developed a model used to forecast the energy demands of New YorkState. Responsibilities included: maintaining the database of time-series input variables to the model; modifying the computer model to reflect changes desired by the economists and urban planners; running the model, creating customized reports; and creating turnkey backup procedures

Had total responsibility for project data processing for a project designed to offer advice to a milk cooperative on improving co-op producer relations. The ability to keep project data processing expenses within budgeted constraints while providing all required services was key to the successful completion of the project.
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