SUMMARY

• SAS Advanced Certified Programmer with 7+years of SAS programming experience in various Pharmaceutical and Biotech industrial setting(s)
• Very good experience in Clinical Data Analysis, Generating Statistical Analysis datasets, Tables, Listings, Graphs and Validations
• Good understanding of International Conference of Harmonization - Good Clinical Practice (ICH-GCP), and FDA guidelines
• Good understanding of different phases of clinical trials and thorough working knowledge of Phases I-IV
• Very good knowledge of Clinical Protocols/ CRF's/Annotated CRF's, NDA, IND, MedDRA, and 21 CFR PART 11
• Extensive experience in SAS/BASE, SAS/STAT, SAS/GRAPH.
• Proficient in working with statistical and report generating SAS procedures such as PROC REPORT, PROC TABULATE, PROC MEANS, PROC SUMMARY, PROC FREQ, PROC CONTENTS, PROC TRANSPOSE, PROC PRINT, PROC UNIVARIATE and PROC CORR
• Excellent knowledge of SAS/ODS to export SAS results into different formats including RTF, HTML, PDF, XML etc.
• Worked with statisticians to analyze the clinical trial data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs) and departmental guidelines
• Experience in handling / working on multiple projects and studies
• Extensive experience with concatenating, interleaving, merging, sorting, printing and reporting data in MS Excel and RTF format
• Experience in Data mapping from non-CDISC SDTM to CDISC SDTM
• Hands on experience in handling clinical trial data such as demographic data (DM), comments (CO), adverse events (AE), laboratory data (LAB DATA), concomitant medications (CM), subject visits (SV) & vital signs (VS)
• Excellent communication skills, a very good team player. Ability to work independently under minimum supervision, in a fast paced environment and under deadlines.

TECHNICAL SKILLS

SAS Tools: SAS 9/9.1.3, SAS/BASE, SAS/GRAPH, SAS/ODS.

Operating Systems: Windows 2007,2010

PROFESSIONAL EXPERIENCE

Clinical SAS Programmer

Confidential - Boston, MA

Responsibilities:

• Responsible for providing SAS programming and analysis support for several studies in close collaboration with Statisticians.
• Develop analysis datasets and generate tables, listings, and graphs as per SAP.
• Participate in statistical program validation and quality control activities.
• Created SAS listings and tables in PDF, RTF formats using SAS ODS.
• Used various procedures like PROC FREQ, PROC MEANS, PROC TABULATE, PROC SUMMARY and PROC REPORT to generate various data tables, patient data listings and reports according to Statistical Analysis Plan (SAP).
• Reviewed CRF's to ensure consistency with protocol and adequacy to collect the data to meet the objectives defined in the statistical section of the protocol.
• Interact with other departments such as Clinical Operations, Project Management, and Data management to ensure a high level of client satisfaction through successful execution of projects.
• Participate in review process of study documents such as CRF, edit check specifications, and database design specifications written by Data Management.
• Responsible for ensuring consistencies in database structures, programming edit checks and data listings, performing validations of programs and participating in database locking activities.
• Reviewed data from clinical trials and developed plans to presenting results to FDA.

Environment: SAS 9.2, Base SAS, SAS Graph, SAS Report, SAS ODS.

Clinical SAS Programmer

Confidential - Carlsbad, CA

Responsibilities:

• Worked on multiple protocols and/or drug compounds at a time.
• Responsible for providing Clinical SAS programming and analysis support for clinical studies across multiple protocols for the submissions like CSR and Safety.
• Generated Tables, Listings and provide QC check, validation of outputs for clinical trials.
• Handled dropouts and missing data by following the conventional approach of Last Observation Carried Forward (LOCF) and Best Observation Carried Forward (BOCF) on visit-wise data.
• Responsible for Developing reports for Safety and efficacy as per study requirements.
• Involved in Developing, Debugging, and validating the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings according to departmental standards.
• Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.
• Performed QC (Quality Check) extensively on tasks performed by other team members and involved in data validation and data cleaning in all phases of Clinical studies.
• Extensively used Proc SQL to retrieve, update and report on information from SAS data sets and other database products.
• Modification of existing SAS programs and creation of new programs using SAS Macros.
• Ability to quickly debug SAS compiling errors, to review SAS code and quickly identify areas of concern.
• Worked with Statisticians and Clinical Data Managers to provide SAS programming in analyzing the Clinical Trials and generating Reports.

SAS Programmer

Confidential - Thousand Oaks, CA

Responsibilities:

• Validated datasets as required by the client to find the missing data and imported to SAS Environment.
• Extracted data from flat files, MS Excel and Oracle Clinical database and created SAS data sets using different SAS procedures and SAS/SQL "Pass through facility".
• Generated Descriptive reports and analysis, basic listings, summary statistics tables, one-way frequencies tables, correlations tables and graphs, and tabular or graphical distribution analysis.
• Involved in generation of analysis datasets such as efficacy, adverse events and demographic data sets from raw datasets.
• Created different listings from raw data for multiple protocols as per templates.
• Used SAS Analytics for Leverage optimization, project scheduling and simulation techniques to identify the actions that will produce the best results.
• Created SAS reports using the Data Null technique and Proc Report for NDA submission as per FDA regulations and company standards.

Environment: SAS 9.1, Base SAS,SAS Graph, MS Excel, MS Access and SAS Report.

SAS Programmer/Analyst

Confidential

Responsibilities:

• Involved in statistical analysis, reporting, and validation.
• Produced quality customized reports by using Proc Tabulate, Proc Report, and Proc Summary and provided descriptive statistics using Proc Means, Proc Freq and Proc Univariate.
• Involved in clinical trials programming of data tables and listings for reporting on safety and efficacy.
• Prepared clinical data listings and summaries for statistical analysis and analyzed clinical data using SAS system.
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/Base and SAS/Macro facility.
• Maintained clinical trial data base, accessed various database to gather data, performed a table lookup and translated data values for meaning and readability.
• Successfully created reports in HTML, PDF and RTF format using SAS ODS.

Environment: Base SAS, SAS Graph, MS Office and Windows.