About Us

Summary
Accomplished SAS Programmer/Analyst with 20+ years of experience in clinical data programming, statistical analysis, and regulatory submissions. Therapeutic area experience includes oncology, metabolism and endocrinology, hematology, nephrology, ophthalmology, infectious diseases, neurology, and cardiovascular.  Skilled in global macro in the areas of SDTM generation from raw data, report generation in WORD ready outputs from a library of FDA recommended standards statistical tables.  Adept in applying software engineering best practices to requirements gathering, prototyping, user acceptance, unit, and integration testing, maintenance, system migration, user support and system documentation meeting 21 CFR Part 11 requirements.  Hands-on experience with supporting CDISC compliant electronic submission. Lead statistical programmer for 2 NDAs and 2 BLAs, highly skilled in processing clinical lab data that pass Pinnacle 21 tests.
 

Skills

• SAS Programming

• Macro Development

• CDISC SDTM/ADaM

• TFL Automation

• Data Integration

• Regulatory Submissions (NDA/BLA)

• Pharmacokinetic Analysis

• Clinical Data Visualization

• Observational Data Analysis

• Quality Control (QC)

• Team Leadership

• FDA/EMEA Compliance
   

Experience

Associate Principal Statistical Programmer                                                                                     10/2020 to 08/2025

Exelixis                                                                                                                                                         Alameda CA 

• Developed global SAS macros to automate common functions used across all clinical study teams. Examples are:

• A raw lab data to SDTM data handling system, including unit conversion, CTCAE toxicity grading and data error reporting.

• A weekly lab toxicity reporting system for clinicians for global study monitoring. Included a summary report of the worst toxicities and provided individual patient lab data in Excel for clinicians to drill down from the summary.

• Developed a lab unit conversion and normal range dictionary used by the lab system.

• Used prototyping to quickly gain insight into user requirements.

• Used functional programming techniques for more reliable and traceable coding by naming SAS work files sequentially.

• Created utilities and techniques for faster development using a minimum of computing resources. Used VS Code editor, Copilot, and saved problematic work datasets in Excel for easier viewing.

• Performed extensive unit and integration testing of the lab system.

• Processed 8 clinical study data with the lab system making enhancements and supporting the lead programmer of each study.

•  Applied software engineering techniques to develop and maintain a validated global macro library.  Examples are:

•  Developed unit and integration test libraries that verify correctness before promoting a macro to production environment

•  Developed utility macros that report data problems to the user via Excel, including user parameter input error, variable and dataset existence checking, data errors like missing lab dictionary entries or lab records with data problems.

• Performed study-level raw data to pre-SDTM dataset building.

• Developed a SAS macro to input Excel pre-SDTM specifications and generate 80% of the SAS code translated the raw data to the pre-SDTM data format.

• Used the code generator on two clinical studies.

• Consulted with CDC on toxicity gradings.

• Ran compliance checks in Pinnacle 21 to validate lab data.
   

Remote Contract SAS Programmer/Analyst                                                                                    10/2019 to 04/2020

UBC                                                                                                                                                        Philadelphia PA     

• Programmed and validated SDTM and ADaM datasets. 

•  Programmed and validated tables and figures.

 

SAS Macro Developer Contractor                                                                                                   11/2017 to 08/2019

Seattle Genetics                                                                                                                                            Bothell WA

• Wrote enterprise-level SAS macros to automate common functions used across all clinical study teams. Examples are:

• Translation of CDISC SDTM and ADAM metadata from in-house system to a Pinnacle 21 upload compliant Excel workbook

• Uploaded adverse event data to clinicaltrials.gov

• Adverse date imputation

• Treatment emergent status of an adverse event

• Date conversion

• Parameter checking utility macros

• Proposed SAS macro to automate common aspects of clinical trials systems reporting and regulatory compliance based on generating where clauses based on output table name mnemonics.

 

Remote SAS Programmer/Analyst                                                                                                   07/2015 to 07/2017

Genentech                                                                                                                                South San Francisco CA

• Developed study-level SAS macros to work with production macro library.

• I wrote specifications, programmed, and validated ADaM datasets.

• Produced TFLs in support of BLAs and regulatory reporting for an oncology therapeutic.

• Used Roche macro system and Genentech mnemonic system to tag output and keep TLF programs as simple as possible.

• Developed reusable code and posted it to a Roche code share Wiki. The Wiki had code, documentation, and a training video using Webex.

• In support of safety update reports, DSUR, pool data across many studies, create specific subsets such as adverse events of interest or patient populations, implement statistical analysis, and produce TFLs that comprise a DSUR.

• In support of periodic benefit-risk evaluation report, PBRER created a SAS Graphic Template Language graph which presented the main benefit-risk factors on one graphic.

• Write SAS macros to automate code list and parameterized file sections of the Reviewer’s guide in an integrated safety and summary submission.

 

Statistical Application Development Manager                                                                                 02/2012 to 05/2015

Gilead Sciences                                                                                                                                       Foster City CA

• Developed 21 CFR Part 11 compliant documentation for their existing global macro library, creating unit and integration test, and business Work Instruction to properly qualify macros for production use.

• Applied software engineering techniques to develop and maintain the global macros which produced word processor ready tables, listings, and graphs.

• Provided user support, fixed bugs, made enhancements, gathered requirements, provided training, and made presentations to the project teams.
   

Sr. Biostatistical Programming Manager                                                                                       10/1997 to 12/2011

Amgen                                                                                                                                           Thousand Oaks CA

• Responsible for the development, maintenance, and support of the global biometrics SAS macro library that automates common programming functions such as TFL generation.

• Managed a team of 5 SAS macro developers in terms of projects, priorities, and responsibilities.

• Handled user support calls, fixed bugs, monitored user acceptance testing and prototyping for enhancements to the global library.

• Applied software engineering and SDLC techniques for 21 CFR Part 11 compliance.

• Provided user support, gathered requirements, and made presentations to user community to provide a consensus solution for new enhancements to the library.

• Developed an interface to the global library to address statistician, medical writer, and programmer requirements.

• Performed exploratory data analysis directed by a statistician and wrote summary documents describing methodology and findings.

• Supported medical affairs statistical programming through data acquisition from NIH, NHANES or DOPPS to perform observational statistical analysis in an effort supplement an NDA or BLA or to expand usage of a marketed drug to other support use in other indications. Developed data acquisition and quality assessment systems to provide clean data for analysis.

•  Lead programmer for an NDA. Programmed graphics and analysis file build programs. Contributed to departmental level macros, documentation, and validation standards. Attended FDA advisory committee meeting.

• For regulatory agency queries, pool data, create subsets from pooled data, implement statistical analysis, and produce TFLs responding to FDA or EMEA questions.

 

Principal Programmer                                                                                                                        01/1994 to 09/1997

Allergan                                                                                                                                                              Irvine CA

• Developed ophthalmologic clinical trials reporting and analysis systems.

• Led NDA statistical programming team on the processing of lab data.

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Lead Medical Programmer                                                                                                               10/1986 to 12/1993

Hoechst-Roussel                                                                                                                               New Brunswick NJ

• Operated, developed, and maintained a macro-based pharmacokinetic reporting and analysis system.  The system calculated pharmacokinetic parameters, performed statistical analysis, automated TFL production, and interfaced with NONMEM, a non-linear population effects modeling program written in FORTRAN. Important features were graphs to automate half-life calculation and present concentration of drug metabolites.

• In support for gaining FDA approval of a validated psychometric instrument, the Alzheimer's Disease Assessment Scale, ADAS.  Developed SAS programs for statistical and graphical exploratory data analysis in Phase II of clinical datasets for Dr. Steven Hardiman and Dr. Bill Blass, the inventor of the ADAS.  The output of these programs presented to the FDA the rationale for the correct factor loading scores for the cognitive, memory, and behavioral components, which was eventually approved by the FDA.  These factor loading values are used by all pharma and biotech companies that summarize ADAS component scores into one value.

• Lead programmer on an NDA and BLA filing.  The BLA had components of non-randomized, observational study data.

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Senior System Analyst                                                                                                                     05/1983 to 09/1986

Miles (Bayer, A.G)                                                                                                                                   New Haven CT

• Developed data entry clinical trials system using the SAS macro language which was used to enter all the data for the Ciprofloxacin NDA submission.  Handled all user support and several migrations over SAS releases and new features.

• Statistical programmer/analyst on the Ciprofloxacin NDA team.

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Education and Training

MS: Statistics                                                                                                                                                   01/1993

Rutgers University

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BS: Accounting                                                                                                                                                01/1977

Penn State University

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Publications

http://www.lexjansen.com/pharmasug/2006/CodersCorner/CC06.pdf

• General Methods to Use Special Characters, contributed "Coder's Corner" presentation, proceedings from the PharmaSUG 2006, The Pharmaceutical Industry SAS Users Group, Bonita Springs, Florida.

http://www2.sas.com/proceedings/forum2007/056-2007.pdf

• Seven Steps to Regulatory Publication Style with Proc Report, contributed "Coder's Corner" presentation, proceedings from the WUSS 2008, The Western Users of SAS Software Users Group, San Diego, CA.

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