Clinical SAS Programming Made Easy

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SAS Programming Made Easy

 

SENIOR SAS CONSULTANT    05/1995 - Present

 

Provided SAS consultancy services to a multitude of clients, including WASA, Cephalon, BD Medical Systems, Astra-Zeneca, DZS Computer Solutions, Boehringer Ingelheim, Smith-Kline & Beecham, and Empirical-Software Engineering Dept. Serve as a vendor to company recruiting services, which in turn serve as a vendor to the company seeking a consultant. 

On assignment with Keane Inc.  Danbury, Connecticut 12/2005 -Present.

 

Migration project (for well-known Parmacetucal Company in the area of Clinical Trails to consolidate many servers into one was undertaken. Pharmaceutical company's clinical project data was on a Sun Solaris Server v9. Primary Role was Project/Technical lead SAS/Perl programmer to create programming scripts for the data migration from Unix to a Windows NT staging area called Cyberlab. 

  • Create Data Archive Master File, which categorizes study data as migrate,archive or delete.
  • Execute parse.pl that will create directory tree structure of archived or deleted data.
  • Create Archived Directory Tree file call ARCHIVED ONLY.
  • Execute parse_archive.pl script, which will contain only Archived Data.
  • Create SearchSASLogs.pl script to check for errors in the creation of SAS transport files.
  • Create Zipdir.pl script to compress top-level directories that contain archived files only.
  • Create  archive_all.pl script to create copy of top level directory, ProdActrs ,ProdGaprs,ProdCdars VolumesSASSY and create SAS transport files of all SAS Datasets.
  •  FTP .bat files that were created by Zipdir.pl to NT staging area called Cyber-Lab.
Clinical trails (Phase-I and III) for well-known Pharmaceutical Company in the area of Oncology for the Prevention and Management of breakthrough Pain was undertaken. Major Role was to assist Primary Clinical Programmer in the development of study’s based on Standardizations (data standards). Create Derived Datasets; Safety and Efficacy tables and listings based on nomenclature in CRF’S, Protocol, Mocks and SAP all to be to be sent to the FDA.

  •  Work with Phase III trial Open-Label 12 Month Study to Evaluate the Safety Tolerability and Efficacy of Pain Management in Opioid-Tolerant Patients with chronic Noncancer Pain.

  • Work with Phase I trial Open-Label, Pharmacokinetic Study to Determine the Maximum Tolerated Dose for patients with Incurable solid tumors or lymphoma. 
  • Work with Phase II trial Open-Label, of Arsenic Trioxide in Patients With Multiple Myeloma.
  • Use of SAS 9.1.3 on Theisis II Server using Windows Xp Code, test and debug SAS programs for the summarization, statistical analysis (descriptive models and others) and reporting on drug efficacy and safety results.
  • Efficacy datasets to include (PSQ) Post Sleep Questionnaire, (BPI) Brief Pain Inventory, Modified Oswestry scale (POMS) Profile of mood states.Generated results of clinical trials in summarized tables and listings according to protocol sections related to data handling, statistical methodology and efficacy results.
  • Extensive coding was involved in base SAS (including Creating Derived Datasets/ Tables and listings using Proc Report) PROC SQL, COMPARE, FREQ, and CONTENTS. CRF/DATA STANDARDS-Review, Map CRF Variables by patient to Listings.
  • Work with Company Macro Directory to Xpedite the Output of integrated summary safety tables and listings and integrated summary efficacy Tables and Listings. 
  • Cephalon training to include: CDISC Study data tabulation Model, Harassment Awareness, Electronic Communication, Adverse Drug Experiences, Code of Conduct.
  • Clincal trails for well-known Pharmaceutical Manufacturing company in the area
 

Clinical trails (Phase-3) for well-known Pharmaceutical Manufacturing Company in the area of Infectious Diseases for the prevention of catheter related blood stream infection was, undertaken. Pharmaceutical company’s clinical project database was (SAS 9.1 as a derivate of Oracle 9i). Primary Role was project lead SAS programmer for Persist Plus as well as Supporting 15 Onsite, Statisticians.Create Analysis Datasets Catheter, AE, Demographics, Risk Factors, Deviation, Site Dress etc...

  • Write Data Specs (Data Dictionary) for the preparation of Analysis Datasets.
  • Write Macro Program to export data from Oracle 9i to SAS data sets (Migration project).
  •  Create Validation Table, Analysis Dataset tracking spreadsheet.
  •  Write 30 programs for edit checking, consistency checks for accuracy of data i.e. integrity checks.
  • Validate listings of Persist Plus Re-analysis sets 1-14.
  • Fix, Debug, and suggest improvements of Persist Plus Re-analysis sets 1-14.

Work with Alexion, MGI, and Pfizer data to produce Validation programs. Generate SAS validation programs to produce summary tables, data listings to accelerate FDA approval.
  • Test and Debug (Validate) SAS macro utility programs for summarization and analysis.
  • Work on Pfizer Study 013372 to evaluate the effects of Celecoxib vs Rofecoxib.
  • Validate listings consisting of, Demog, Treatment Emergent AE, Labs, Water Displacement.
  • Validate listings consisting of 12-Lead Ecg, Labs, and Inclusion/Exclusion Criteria.
  • Modify and update program information sheet and listing specifications.
  • Sign off on 15 SOPS

 

Clinical trails (Phase-3) for well-known Pharmaceutical Company in the area of Neurology for the Prevention of Acute Ischemic Stroke were undertaken. Primary Role was to assist Principle Programmer in the development of the study based on specifications (data specs). Create Analysis Datasets, Safety and Efficacy tables and listings based on nomenclature in CRF’S, Protocol, Output templates and SAP all to be to be sent to the IDMB.
  • Consulting clinical trails (phase 2-3) for both US and Swedish branch of Corporation.
  •  Work with 200,400,700 Interim Analysis Patient transfer for anti stroke medication cerovive to be sent to the IDMB (International Data Monitoring Board).
  • Use of SAS 8.2 on Unix, NT and Swedish based CDX system (Visual Source Safe).
  •  Work in Unix environments CSRE (Clinical Study Reporting Environment) & ICE Integrated Computing Environment.(CDE Common Desktop Environment via Reflections.
  • Code, test and debug SAS programs for the summarization, statistical analysis (descriptive models and others) and reporting on drug efficacy and safety results.
  • Efficacy datasets to include mRS-Modified Rankin Scale, NIHSS-National Institute Health Stroke Scale, Barthel Index.
  • Generated results of clinical trials in summarized tables and listings according to protocol sections related to data handling, statistical methodology and efficacy results.
  • Extensive coding was involved in base SAS (including Creating Analysis Datasets/ Tables and listings using Proc Report), SAS/ACCESS, SAS/STAT, and PROC SQL.
  •  Wrote the functional design specs and defined the process workflows.
  • Develop Macros to Xpedite the Output of integrated summary safety tables and listings. Summary efficacy Tables and Listings to be used in the presentation of the Common Technical
  • Document. Use of CR Toolkit to produce tables and listings.

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