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Clinical Sas Programmer Resume

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Blue Bell, PA

SUMMARY

  • Certified BASE SAS programmer dedicated to a career in the field of statistical programming in the pharmaceutical and biotechnology industry.
  • Experienced in working closely with statisticians in analyzing clinical trials data, generating and validating Safety and Efficacy Analysis Datasets, Tables, Listings, and Graphs for producing Clinical Study Reports compliant with FDA guidelines.
  • Significant experience in creating, maintaining, and validating analysis datasets using various SAS procedures from raw datasets and also from other data file formats such as CSV files, Microsoft Excel spreadsheets and Oracle Databases.
  • Experienced in using SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/ODS, SAS/GRAPH, and SAS/ACCESS on Windows and UNIX operating systems.
  • Proficient in developing and debugging SAS MACROS for improving programming efficiency.
  • Familiar with FDA regulations, 21 CFR Part 11, GCP and ICH guidelines.
  • Experienced in carrying out all activities in accordance with organization’s standard operating procedures (SOP’s) working within the framework of the quality management system to good clinical practices (GCP’s).
  • Fair knowledge of CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) structures.
  • Creative problem solver possessing strong academic understanding of data analysis; Results driven professional with proven talent to meet or exceed company goals;
  • Effective communicator adept at relating with both professional and community audiences; comprehensive project management and organizational skills gained through various job responsibilities.

TECHNICAL SKILLS

SAS Programming Tools: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ODS, SAS/STAT and SAS/GRAPH.

Databases: ORACLE, MS ACCESS

Languages: C, SQL and PL/SQL

MS Tools: MS Excel, MS Word, MS PowerPoint, MS Access

Operating Systems: WINDOWS 98/XP, UNIX (Sun 9)

PROFESSIONAL EXPERIENCE

Confidential, Blue Bell, PA

Clinical SAS Programmer

Responsibilities:

  • Serve as lead programmer on 2 studies while at PRA. Responsible for delivery timelines co - ordination and interaction with clients.
  • Project management and maintaining communication with client and other departments involved in study.
  • Overseeing and mentoring several junior programmers in PRA.
  • Extensively used SAS STAT procedures like FREQ, MEANS, UNIVARIATE, MIXED, to perform various statistical analysis
  • Developed and maintained SAS macros for improving the efficacy of the program by automating the process of generating different tables and summary reports for FDA submissions.
  • Creation of Dataset specifications for Analysis datasets
  • Produced/Validated Tables, Listings and Figures as per Statistical Analysis Plan
  • Produced/Validated Analysis datasets
  • Used SAS ODS for generating reports in specific output formats like Excel, PDF etc.
  • Created specifications for ADAM based analysis datasets
  • Produced safety TLs for DMC submissions
  • Carried out all activities in accordance with SOP’s working within the framework of the Quality Management system to Good Clinical Practices (GCP’s).
  • Worked on creating define.xml outputs for SDTM and ADaM, for submission purposes.

Confidential, North Wales, PA

Clinical SAS Programmer

Responsibilities:

  • Performed data validation and edit checks on clinical data for creating SAS datasets or files. Worked closely with statisticians to resolve the identified data issues and data discrepancies.
  • Developed, validated and documented programs to create tables, listings and figures as per Statistical Analysis Plan (SAP) using SAS reporting procedures such as PROC REPORT, PROC PRINT, DATA NULL graphic procedures like PROC GPLOT, PROC LIFETEST and statistical analysis procedures like PROC MEANS, PROC UNIVARIATE, PROC MIXED, PROC GLIMMIX and PROC FREQ.
  • Developed and maintained SAS macros for improving the efficacy of the program by automating the process of generating different tables and summary reports for inclusion in clinical study reports.
  • Coordinated in pooling data across multiple protocols for creating integrated summaries of safety and efficacy (ISS/ISE).
  • Coordinated in implementing CDISC submission data standards (SDS V3), Study Data Tabulation Model (SDTM V3.1) and Analysis Data Model (ADaM) structures for FDA submissions.
  • Acted as a Lead Programmer for preparing IND and DSMB reports for studies.
  • As a Lead Programmer, planned, organized and managed the activities of the statistical programming team for efficient delivery of high-quality tables, listings and graphs; managed project/study related specific activity and provided ongoing updates and adjustments to the appropriate project manager.
  • Carried out all activities in accordance with ICON SOP’s working within the framework of the Quality Management system to Good Clinical Practices (GCP’s).
Environment: Windows NT, SAS/Base, SAS/STAT, SAS/Access, SAS/EG, MS Excel.

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