NORMAN A. SPIER, Ph.D.

Available for Contract Analysis and Programming Services Through:

N.A.S. Technical Services, Inc.

607-797-3296

norm@nastechservices.com

Work is primarily at my site, part time to full time, as needs require.

(NOTE: We are located in Vestal (near Binghamton), NY State, about 2 hours from the NY/NJ pharmaceutical company concentration.)

Statistician, with extensive experience at the programming aspects of analysis, as well.

Experience is extensive (15+ years) in the clinical trials aspect of pharmaceutical development (using SAS). I also can provide services with other software tools, and in other areas of application, though my experience is more limited. (Outside of clinical trials, I have a few years of experience in quality control, and general scientific/engineering programming.)

SKILLS

• Substantial formal training in statistics, computer science, and mathematics

• Extensive experience analyzing data, and programming analysis software, for a wide range of applications.

• Languages used include SAS (15+ years). I also have lesser levels of experience with C++, Oracle PL/SQL, Java, S-Plus. Knowledge includes interfacing between products. Worked with Unix/Linux, Windows, VAX/VMS, OS/2.

• Work is characterized by accuracy, and an efficient, systematic approach. This yields notably consistent and accurate results.

• Programs designed and written are carefully thought out for extensibility, and are typically reused with modification.

• Understands issues related to structure of database data: designs good database structures, and deals well with data already in a database in a pre-determined structure

• Many years of experience designing and programming combined-study analyses, combining somewhat disparate efficacy and/or safety data from between 6 and 37 studies.

• Much of the analysis work over the years has had graphical output. Often, this output was needed to be polished and highly informative, and therefore graphics primitives (SAS GANNOTATE/GSLIDE) were used in preference to higher-level routines (such as GPLOT).

SKILLS, continued

• Style is adaptive, responding to issues and needs that become apparent as the project unfolds, and as data subtleties emerge

• Nice, detailed documentation, when appropriate, and when resources permit.

• Quantitative and economic good sense: weighs costs and benefits in design and analysis issues

• Good communication skills

§ Team-oriented

§ Work is timely. (This is based on a well-thought-out and careful approach, rather than a poorly-engineered-but-frenetic approach.)

CONTRACT STATISTICS AND STATISTICAL PROGRAMMING (Self-Owned 1995-

N.A.S. Technical Services, Inc.)

Major Contracts Include:

· Boehringer-Ingelheim (Pharmaceutical) 2003-2006

Statistician for clinical trials. (Respiratory Drugs; SAS on Windows/Unix hybrid system.)

Main work (2.5 years) was numerous ad-hoc analyses, mostly quite large. These were of efficacy parameters to support marketing and publications, or of safety parameters, for internal vigilance use, or at the request of regulatory agencies. Most of these analyses were all on sets of between 9 and 37 studies.

These analyses required design and construction of several large pooled-study datasets unIfying disparate data from various sources. They also required construction of software routines doing non-graphically-presented and graphically-presented time-to-event analyses (Kaplan-Meier, Cox Regression, Incidence-Density, etc, often presented graphically).

Though analyses were numerous and extended over a 2.5 year period, the technique was to create a small number of well-documented datasets, and well-thought-out programs, and extend the datasets when new studies were added, and extend and/or modify the analysis programs when new analyses were needed.

Except for some of the second-person validation, virtually all of the above work was done by me alone. There was extensive interface with other statisticians, physicians, and the data group, to maintain consistency with previous analyses, comprehend the input data, and get the exact needed product.

Prior to this (0.5 years) , performed the efficacy analyses for a pair of COPD-drug studies.

EXPERIENCE, continued

· Purdue Pharma, L.P. (Pharmaceutical) 1996-2001:

Designed, programmed, documented, and validated a large portion of software to support several New Drug Applications. This was programming for the full submission process, with each stage thought through as much as possible to support later stages.

As part of above task, programmed individual-study efficacy and safety analyses. Created well-documented intermediate datasets to support pooling. Also, designed and documented pooled safety dataset structures. Design was in a fashion flexible enough to incorporate unknown future studies. Then, when these future studies came into existence, expanded the pooled datasets and documentation.

Programmed much of the analysis software that used the above pooled datasets. This was well-conceived, well-documented, highly accurate macro-based software that had the ability to flexibly handle large numbers of tables of several different formats on the pooled data structure.

Did other efficacy and safety analysis and reporting programming. This included imputation of estimated adverse event durations on some long studies with incomplete data.

Did quality checking on pooled-analysis software from outside vendor.

NOTE: The Purdue contract was a contract that was renewed for almost 5 years due to client satisfaction. Contract ended only due to newly imposed contract-duration-related company policy.

Most work done at Purdue was for pain medications, and in SAS, with extensive SAS macro / SAS PROC SQL, and SAS Graph on Unix.

· Blue Cross/Blue Shield of Connecticut:

Programmed and maintained programs for data-warehousing and general business-reporting applications.

PFIZER INC, Groton, CT 1988 - 1995

Statistician, Clinical Drug Trials

· Did general study planning, analysis, programming, and validation for clinical drug trials, particularly the efficacy aspect. Was principal statistician for Zithromax antibiotic. Work included some complicated pooled efficacy analyses. Wrote sections of protocols, analysis plans, and sections of study reports. Oversaw and checked work of outside vendors.

· Work was primarily on antibiotics, but also did some work on other types of drugs. Some work was on pre-clinical studies. Programming was in SAS on VMS.

EXPERIENCE, continued

GENERAL ELECTRIC COMPANY, Binghamton, NY 1984 - 1988

(Internship)

Statistician and Computer Programmer, Quality Information

· Designed and did computer programming of a quality monitoring system for circuit boards. (Fortran interfacing with a database on VMS.)

· Consulted with quality control personnel concerning the use of statistical tools.

MITRE CORPORATION, Bedford, MA 1980-1981

Computer Programmer, Electronics Engineering

· Programmed electronics-engineering related applications. (C, Fortran, various Assembler languages.)

EDUCATION

Ph.D., Mathematical Statistics, State University of New York at Binghamton, 1988.

M.A., Mathematics, State University of New York at Binghamton, 1980.

B.S., Mathematics and Computer Science, State University of New York at Binghamton, 1978.

REFERENCES

Gladly furnished on request.