Morris Lee

Staff Programmer at Edwards Lifesciences

Location
Orange County, California Area
Industry
Medical Devices

As a LinkedIn member, you'll join 300 million other professionals who are sharing connections, ideas, and opportunities.

  • See who you and Morris Lee know in common
  • Get introduced to Morris Lee
  • Contact Morris Lee directly

View Morris's full profile

Morris Lee's Overview

Past
Education
Connections

192 connections

Websites

Morris Lee's Summary

Senior Statistical Programmer/Analyst with 10+ years experience in biotechnology/pharmaceutical research. Consistently performing higher level tasks such as developing and maintaining programming infrastructure, mentoring more junior level programmers, and making high level educational presentations to non-technical staff. Highly successful in teaming with statisticians, data managers, programmers and external vendors to extract, clean, report and analyze data. MPH Biostatistics.

Specialties

SAS

Morris Lee's Experience

Staff Programmer

Edwards Lifesciences

Public Company; 5001-10,000 employees; EW; Medical Devices industry

January 2012May 2014 (2 years 5 months) Irvine, CA

• Programming lead for PARTNER II trial (http://clinicaltrials.gov/ct2/show/NCT01314313) … PMA submission April 2013
• Generate database specifications; program analysis datasets and outputs (baseline, safety, efficacy); run annual updates on baseline and safety data; provide adhoc and weekly reporting / analysis on enrollment, compliance and safety data
• Manage on-site contract programmers (division of labor, timelines, quality control)
• Evaluate and maintain integrity of annotated CRFs, dataset and programming specifications
• Develop macro utilities to increase report storage efficiency

• Develop departmental SOPs: Edit Check Validation for Endpoints, Statistical Programming Validation

• Provide programming support for other studies as needed (QC, dataset/output generation, database discrepancy reports for Data Management)

• HEART award recipient April 2013 (Edwards employee recognition program)

Statistical Programmer Analyst

Genentech

Privately Held; 10,001+ employees; Biotechnology industry

September 2010January 2012 (1 year 5 months)

• Recognized for extraordinary productivity, Nov. 2011
• Programming in UNIX environment using DATA NULL, PROC SQL, SAS/STAT, SAS/GRAPH, PROC REPORT with ODS RTF and macros to generate analysis datasets, customized analysis tables and listings for Phase Ib/ II Non-Hodgkins Lymphoma and Non-Small Cell Lung Cancer IND/IB updates and clinical study reports (CSRs), Phase Ib/II ophthalmological (geographic atrophy) IND/IB updates and CSRs.
• Lead SPA responsibilities:
• work with Project Evaluation Team members (including biostatisticians, data managers, clinical scientists)
• manage off-site contract programmers (division of labor, timelines, quality control)
• evaluate and maintain integrity of annotated CRFs, dataset and programming specifications
• self-train, as needed, on programming and database tools in order to accomplish tasks (e.g., standard analysis reporting macros)
• maintain SPA user tools (e.g., maintain look-up tables and integrity of units for lab data processing) and develop new ones as needed

Contract Statistical Programmer

Exelixis

Public Company; 201-500 employees; EXEL; Biotechnology industry

May 2010September 2010 (5 months)

• Programming in UNIX environment using DATA NULL, PROC SQL, SAS/STAT, SAS/GRAPH, PROC REPORT with ODS RTF and macros to generate analysis datasets based on SDTM compliant raw data, customized analysis tables and listings for oncology studies (internal review and ASCO submissions … Phases II and III). Monthly, quarterly reporting of safety and efficacy data.
• Validation of other programmers’ code to provide enhancements and efficiencies: review of SAS logs, PROC COMPARE, write independent programs and macros to replicate results
• Assist in the creation and validation of CDISC/SdTM data specifications, programming of edit check reports for SdTM data transfers

Contract Statistical Programmer

Roche Molecular Systems

Public Company; 1001-5000 employees; Biotechnology industry

December 2009May 2010 (6 months)

Contract Statistical Programmer for Biostatistics group at Roche Molecular Systems
• Programming in PC environment using DATA NULL, PROC SQL, SAS/STAT, SAS/GRAPH, PROC REPORT with ODS RTF and macros to generate analysis datasets based on SDTM compliant raw data, customized analysis tables and listings for diagnostics studies (internal review and submissions to FDA). Studies include: qualitative comparisons between screening devices (percent agreement analysis, sensitivity/specificity analysis, protocol deviations); evaluation of assay used to detect gene mutation in patients with metastatic melanoma (open label Phase II and III)
• Validation of other programmers’ code to provide enhancements and efficiencies: review of SAS logs, PROC COMPARE, write independent programs and macros to replicate results

Senior Statistical Programmer

Cytokinetics

Public Company; 51-200 employees; CYTK; Biotechnology industry

November 2007November 2009 (2 years 1 month)

Senior Statistical Programmer for Biometrics
• Programming in PC environment using DATA NULL, PROC SQL, SAS/STAT, SAS/GRAPH, PROC REPORT with ODS RTF and macros to generate analysis datasets, customized analysis tables and listings for cardiology (including submission to Amgen (Omecamtiv Mecarbil) for $50 million partnership) and oncology (ASCO conferences and IND reports) clinical studies
• Validation of other programmers’ code to provide enhancements and efficiencies: review of SAS logs, PROC COMPARE, write independent programs and macros to replicate results
• Develop in-house SAS macros for set-up of global environment, analysis datasets, standardized reports (AE, labs, etc.)
• Write SOPs to develop programming standards within the department
• Work with external CROs to coordinate tasks, inform of programming and database issues
• Coordinate meetings with outside vendors to evaluate software and services for CDISC implementation
• Data Management tasks:
• Macro SAS programming of customized edit checks
• PROC COMPARE of past and current data uploads to assure consistency
• Verifying data transfers against annotated CRFs and database specification documentation
• Verifying annotated CRFs and database specifications for SDTM v3.1.2 compliance
• Importing/exporting data across different platforms

Statistical Programmer

PDL BioPharma

Public Company; 501-1000 employees; PDLI; Biotechnology industry

June 2006November 2007 (1 year 6 months)

• Programming in PC environment Base SAS, PROC REPORT, SAS/STAT, SAS/GRAPH and macros to generate analysis datasets, tables, graphs and listings for Phase I, II, III studies in oncology, heart failure, Crohn’s Disease
• Validation of other programmers’ code to provide enhancements and efficiencies: review of SAS logs, PROC COMPARE, write independent programs and macros to replicate results
• Provide input for improvement of statistical analysis plan clarity, review of CRFs and data transfer specifications for consistency and accuracy

Statistical Programmer

Gilead Sciences

Public Company; 5001-10,000 employees; GILD; Biotechnology industry

June 2004May 2006 (2 years)

• Programming in UNIX environment using DATA NULL, PROC SQL, SAS/STAT, SAS/GRAPH, and macros to generate analysis datasets and customized analysis tables and listings for Phase II and III hepatitis clinical studies
• Validation of other programmers’ code to provide enhancements and efficiencies: review of SAS logs, PROC COMPARE, write independent programs and macros to replicate results
• Provide Item 11 documentation for submission of clinical reports to FDA
• Provide input for improvement of statistical analysis plan clarity, review of CRFs and data transfer specifications for consistency and accuracy
• Interdepartmental presentations on SAS Certification processes and feasibility of data warehousing system and PHARMASUG presentation on usage of comments system tool
• Maintenance and updates of company-developed comments system tool

Statistical Programmer

Chiron Corporation

Public Company; 1001-5000 employees; CHIR; Biotechnology industry

January 2003April 2004 (1 year 4 months)

• Programming in MVS environment using DATA NULL, PROC SQL and macros to generate customized analysis tables and listings for old clinical studies
• Validation of other programmers’ code to provide enhancements and efficiencies: review of SAS logs, PROC COMPARE, write independent programs and macros to replicate results
• Provide written updates to program functional specifications to help educate other programmers
• Develop test plan and test code to validate standard programs to be used in the future

Statistical Programmer

La Jolla Pharmaceutical Company

Public Company; 1-10 employees; LJPC; Biotechnology industry

20022002 (less than a year)

Database Marketing Analyst

Charles Schwab

Public Company; 10,001+ employees; SCHW; Financial Services industry

20002002 (2 years)

IT Analyst

Searle

Public Company; 10,001+ employees; Pharmaceuticals industry

19971999 (2 years)

Morris Lee's Skills & Expertise

  1. SAS
  2. Clinical Trials
  3. Macro development
  4. Staff Supervision
  5. SOP development
  6. Macro
  7. CDISC
  8. Statistical Programming
  9. SAS programming
  10. Regulatory Submissions
  11. Data Analysis
  12. Data Management
  13. CRO
  14. Unix
  15. Clinical Data Management
  16. SDTM
  17. Oracle Clinical
  18. EDC
  19. Oncology
  20. Validation
  21. Biostatistics
  22. Clinical Research
  23. 21 CFR Part 11
  24. Clinical Development
  25. Protocol
  26. GCP
  27. Sop
  28. FDA
  29. Statistics
  30. CTMS
  31. ICH-GCP
  32. Clinical Study Design
  33. CRF design
  34. Inform
  35. Data Warehousing
  36. Medidata
  37. Infectious Diseases
  38. Drug Development
  39. Pharmaceutical Industry
  40. Biotechnology
  41. Computer System Validation
  42. Databases
  43. Software Documentation
  44. Clinical Monitoring
  45. Lifesciences
  46. Survival Analysis
  47. Medical Devices
  48. Data Validation
  49. Biopharmaceuticals
  50. Programming

View All (50) Skills View Fewer Skills

Morris Lee's Education

Columbia University Mailman School of Public Health

MPH, Biostatistics

19901992

Princeton University

AB, History

19861990

Winner of University concerto competition, soloist with University Orchestra 1990

Activities and Societies: Glee Club, Orchestra

Contact Morris for:

  • expertise requests
  • reference requests
  • getting back in touch

View Morris Lee’s full profile to...

  • See who you and Morris Lee know in common
  • Get introduced to Morris Lee
  • Contact Morris Lee directly

View Morris's full profile

Not the Morris Lee you were looking for? View more »

Viewers of this profile also viewed...