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Clinical Data Manager Resume

Fresh Meadows New, YorK

PROFESSIONAL EXPERIENCE

Confidential, New York, New York
Clinical Data Manager

Maintaining and mgt. of NOMASS (NOrthern MAnhattan Stroke Study) database of longitudinal
cohort of cases/controls developed in SAS 8.2. Extracting datasets for biostatistical analysis using
SAS® 9 and/or MS Access 2002 (SQL queries). Statistical programming and analysis with SAS 9.
Mentoring MD/MPH/DrPH students in SAS programming.

Confidential, 7/06~10/06 New York, New York

Clinical Database Manager

Responsibilities included developing Case Report Forms and clinical database schema

Montefiore Medical Center (MMC)/Albert Einstein Cancer Center 12/02~6/06

Department of Oncology: Office of Clinical Trials
Bronx, NY
Senior Clinical Systems Analyst

Responsibilities included uncovering existence of alternative software systems and processes.
Development of software solutions to clinical data management and administrative workflow
hotspots. Adapting in-house, applications to off-menu requirements of different research
protocols. Interactions with Bio-Informatics Group. Ad hoc biostatistical consultations.

ACHIEVEMENTS

  • As a member of a team comprising Director of Clinical Trials Office (Department of Oncology), clinical research nurses and administrative co-coordinator, was responsible for developing the CTO (Clinical Trial Office) clinical data management software system using Microsoft Access 2000. This application was showcased to representatives of the NCI at the CaBIG interview at AE Cancer Center in September 2003.
  • Using MS Access 2000, designed and authored centralized, Medical Oncology Research
    Screening Log (MORSL) database management system for use by co-coordinators and data
    managers of the Oncology department at scattered Montefiore Medical Center offices
  • Developed PRMC (Protocol Review Monitoring Committee) database management system for use by the Director of CTO and his Administrative Co-coordinator using Access 2000
Confidential. 3/00~6/02

Stamford, CT
Senior Clinical Systems Analyst


Responsibilities included investigating the existence of, testing, implementation, and

maintenance of systems which facilitate the processing, analysis, and reporting of
pharmacokinetic, clinical, and laboratory data utilized in the submissions of NDAs. Review
and evaluation of new information technology and proposals from outside vendors for part
or all of contracted projects, potentially including management of contract consultants.
Provided ad hoc programming support for integrated statistical/clinical reports and might be
called upon to provide training and consulting to biostatistics/clinical data management
department. Hardware and software used: PC and HP-UX. Served as Administrator of
Merant's PVCS VM (Version Manager) source code control product. Ad hoc SAS
programming (6.12). Member of SAS Version 8.2 Upgrade Team.

ACHIEVEMENTS

  • Developed in-house PVCS Version Manager training program which was well received by Data Managers, Statistical Programmers, etc. etc. in attendance
  • Designed, developed and assisted in the testing of OQ (Operat'nl Qualifications) and PQ (Process Qualifications) test scripts for in-house validation of PVCS VM software product

Confidential, 3/96~12/99
Columbia, MD
Clinical Data Manager

Responsibilities included design of data entry screens using SAS FSP in FDA clinical trials
of human vaccines. Training of data entry staff and clinical research monitors in use of SAS
software to perform ad hoc entry, queries, review of clinical database. Biostatistical analysis
of clinical trial safety and efficacy using SAS, StatXact, DBMS/COPY software in a blended
Windows 95 PC & Sun Unix environment. Collaboration and consultation with clinical
investigators. Assessment of sample size needs and statistical power analysis of clinical
trials, randomization lists using SAS. Ad hoc consultations with members of other research
departments involving non-clinical statistical issues (e.g., performing product stability
analysis). Design, development and management of DataFax data entry screens and clinical
trial schemas for FDA CAPLA data submission. Edit check creation.


ACHIEVEMENTS

  • Initiated and authored successful proposal to re-engineer data management around more cost-efficient, fax based receipt and management of CRFs using CDSI's DataFax software, netting monthly savings of $50,000 - $70,000.

Confidential, 12/94~2/96
Senior SAS Programmer

Responsibilities included oversight of computing productivity and internal SAS training.
Programming and statistical analysis using MS WINDOWS SAS® and other software:
complex data step programming and data management resulting in sorts, merges, arrays,
constructed/derived variables, etc. Use of diverse SAS BASE, STAT, FSP and MACRO

ACHIEVEMENTS

  • Authored and codedprogram to perform linkage analysis of data arising from need of US
  • Substance Abuse and Mental Health Agency's mandate to augment the National Facility
  • Registry of treatment centers, using AutoMatch software in tandem with other SAS
  • software products.

Confidential, 12/91~12/94
Senior Biostatistician

Using SAS (BASE, STAT, GRAPH, ETS, FSP, MACRO) 6.0X, software, analyzed and
managed large and complex clinical datasets with UNIX (SunOS) and PC WINDOWS
based computer hardware. Ad hoc supervision and training of junior group members.

ACHIEVEMENTS

  • Authored SAS program to create a dataset "codebook" to enhances information from PROC CONTENTS. Subsequently provided it to SAS Institute technical staff to be
    reviewing for future appearance in SAS Institute's publications.
  • Designed an innovative SAS program that is useful in assessing the impact of time- dependent covariate when modeling clinical trial data with proportional hazards regression
    analysis and SAS PHREG. It appears in “Survival Analysis Using The SAS®
    System” (Paul Allison, 1995), with acknowledgments by the Author.
  • Served as the SAS Site Representative.

Confidential, 10/87~12/91
Manager, Biostatistical Systems

Coordinated planning, analysis and data management of human clinical trials and other
health-related biomedical research. Trained computer users (researchers) in use of computer
software such as VAX/PC SAS (BASE, STAT,GRAPH, ASSIST) 6.0X, CLINFO 2.1,
WordPerfect 5.X in a DEC VAX environment (under VMS 5.X).

ACHIEVEMENTS

  • Developed VAX/PC SAS (6.0X) macro to compute Lin's (Biometrics,1989) Coefficient of Concordance statistic.

ACHIEVEMENTS (cont'd)

  • Implemented O'Brien and Muller's SAS (6.0X) routine for statistical power analysis calculations.
  • Co-authored published medical journal article based on SAS STAT data analysis of cardiac output data.
  • Co-authored published medical journal article describing implications of Generalizability Theory for sample size determination in human clinical trials using
    GENOVA and SAS STAT data analysis.
  • Served as SAS Site Representative.

Confidential,California 6/86~10/87
Consultant

Offered ad hoc guidance on design of research projects, data layout, and statistical analysis
to students.

Confidential, 6/81~6/86

Biostatistician

Conceptualized and planned experimental designs with biomedical scientists studying
health-related effects of air pollution. using BMDP and FORTRAN, performed
management and analysis of research data on a DEC PDP 11/23 computer. Collaborated on
grant proposals and final reports. Assisted with graph and table preparation using BMDP.

ACHIEVEMENTS

  • Co-authored technical reports and articles appearing in peer-reviewed biomedical journals.
  • Authored and utilized data validation, quality assurance software using FORTRAN which generated significant reduction in throughput times to analysis combined with improved data integrity.

Confidential,
Statistical Computing Consultant

Mentored graduate Physical/Occupational Therapy students with respect to statistical and
data management related issues pertaining to their Masters research projects. Trained post-
graduate students and Research Fellows in data analysis using software such as SPSS,
BMDP and SAS in an IBM mainframe environment. Analyzed research data using the same
software.

ACHIEVEMENTS (cont'd)

Co-authored published paper discussing the discovery of unexpected statistical
relationships between perturbations in depth of surgical incisions made while performing
radial keratotomy and the surgical endpoint using BMDP software on IBM mainframe.

EDUCATION
Post-graduate coursework in Biometry
M.A. Industrial Psychology

B.A. Psychology

ADDITIONAL TRAINING/MEETINGS:

Advanced Data Analysis Workshop, 1983 Confidential
ANOVA and MR Workshop, 1985 Confidential
Data Monitoring in Clinical Trials Workshop, 1985 Confidential
Regression Fitting on Real Data Workshop, 1985 Confidential
Ass'n of Gen'l Clinical Rsrch Centers System Mgrs Annual Mtgs, (NIH, 1988- 91 (N.I.H.)
Ass'n of General Clinical Research Centers Biostatisticians Annual Meeting, 1991 (N.I.H.)
Southeast Region SAS Users\' Group Meeting (SESUG), February 1993
SAS Users Group International (SUGI) meetings #14, #22, and #24
PharmaSUG Annual Meeting, 1998
Computer System/Software Validation Confidential 2000
Advanced (SAS) Programming Techniques and Efficiencies Confidential 2000
SAS "PROC REPORT" training (In-house at Purdue Pharma, L.P.), 2000
PVCS Version Manager for Administrators 6.6 Confidential 2000
Building a Clinical Data Warehouse Using the PH.DataWare System Confidential 2000
Drug Information Association Annual Meeting, 2001
SAS Software Version 8.2 Changes and Enhancements Confidential 2002
The Output Delivery System In SAS Software Confidential 2002
Mastering MS Access 2000 Programming Confidential 2003
Introduction To SQL 12.5 Confidential 2003

VOLUNTEER

Clinical Database Developer/Analyst
Lang Institute for Research and Education
New York Hospital (Queens)
New York, N.Y.

Bibliography & References Furnished Upon Request

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