PROFESSIONAL SUMMARY:

• A results - oriented SAS programmer with over 7 years of programming experience covering all aspects of clinical data analysis in Pharmaceutical & Biotech with proven technical and project management leadership skills.
• Proficient in understanding clinical trials study designs, study protocols, statistical analysis plans (SAP), case report form (CRF/eCRF), annotated case report forms, and company standard operating procedures (SOP).
• Extensively involved in Clinical Data Analysis and programming of SAS Datasets, generating reports, creating tables and listings according to the Statistical Analysis Plan and departmental guidelines.
• Developed new or modified existing SAS programs to load data from the source and create study specific datasets.
• Created SDTM and ADaM datasets following CDISC standards.
• Proficient in various SAS report generating procedures like Proc Report, Proc Means, Proc Tabulate, Proc Transpose, Proc SQL, Proc Format, Proc Compare and Proc Print, SAS/STAT procedures like Proc Freq, Proc Means, Proc Univariate and SAS data steps such as ARRAY, MERGE, SET, and SAS ODS options like HTML, CSV, XML, PDF etc.
• Experienced in programming and using existing SAS MACROS to generate Tables, listings and datasets
• Worked with different clinical trials data that includes Demographics, Adverse Events, Serious Advents Event (SAE), Lab data etc.
• Experienced in Ad-Hoc Programming.
• Experienced in producing RTF, HTML and PDF formatted files using SAS/ODS.
• Proficient in handling / working on multiple projects and studies.
• Excellent skills in diagnosing and avoiding errors, understanding and enhancing output to furnish reports.
• Effective team player with strong communication and interpersonal skills.

CORE COMPETENCIES INCLUDE:

• Define docs
• ADaM
• SDTM
• Adhoc Reporting
• RTF Reporting aCRF

TECHNICAL SKILLS:

Operating Systems: SAS, SAS/BASE, SAS/STAT, SAS/MACROS, SAS/SQL, SAS/ODS, MedDRA, WHODrug

MS office: Word, Excel, Power Point, WINDOWS

EXPERIENCE:

Confidential

Statistical Programmer

Responsibilities:

• Pharmaceutical Data received from data vendors in form of .txt files, Excel files.
• Extracted raw data using SAS/BASE and created SAS data sets that are required for the project analysis.
• Extensively involved in Clinical Data Analysis and preparation of SAS Datasets, according to the Standard Operating Procedures (SOPs) and departmental guidelines.
• Cleaning, validating, sorting and merging techniques is done using SAS/Base include Macros and SQL.
• Created SDTM domains and Analysis datasets (ADaM) according to CDISC standards and Statistical Analysis plan (SAP).
• Generated Tables, Listings and Graphs as per Mock shells and SAP.
• Used statistical procedures Proc Freq, Proc Means and Proc Univariate.
• From the processed data several reports were generated used Proc Report and also converted the data into RTF format by using ODS.
• Used SAS/Macros extensively in analysis of standard clinical data and generated reports, graphs, listings and tables.
• Proficient in understanding of Case Report Forms (CRF’s), annotated CRFs, and Study related documentation.
• Involved in creating project specific datasets and tables for interim analysis.
• Involved with the Validation of SDTM datasets, ADAM datasets
• Programmed XPT files outputs for adjudication data transfers to different clients.
• QC of analysis datasets programmed by other programmer by parallel programming.
• Provided monthly reports and ad hoc reports as per request for different pharmaceutical companies across corporate organization.
• Strong experience in Base SAS, SAS/Macros, SAS/STAT, SAS/ODS and SAS/SQL.
• Developed the SAS programs for different tables like Adverse Events, Vital signs, Laboratory, Demographic tables, Listings for different therapeutic areas.
• Validation on Summary tables and document the issues raised on validation to coordinate with primary programmer or project Lead for final run reports.
• Experienced in producing RTF, PDF, and HTML files using SAS ODS facility.

Confidential, Cary, NC

Clinical SAS Programmer

Responsibilities:

• Provided SAS programming for supporting Statistical departments.
• Converted the clinical trial data, subject records entered in the database files to SAS datasets.
• Developed SAS programs using Base SAS for counts, sorting and merging data validations using PROC Means, PROC Freq.
• Specifications mapping, creation, and validation of ADaM and SDTM datasets for e-submission to the FDA in accordance with CDISC standards.
• Created Data Definition Documents (DDDs) like Define.xml
• Annotation of the electronic CRF for submission of CDISC data sets.
• Production and validation of various tables, listings and graphs (TLF's) per the SOP
• Extensive creation of ODS RTF reports and a good knowledge of RTF in general.
• Converted SAS listings and tables into PDF, RTF, HTML formats to meet specifications by using SAS ODS.
• Supported for SAS transport files for regulatory submissions.
• Provided programming support for the creation and maintenance of programs used in data validation, and statistical report generation.
• Developed, modified and generated reports summarizing business activity using Proc Univariate, Proc Copy, Proc Transpose, Proc Report, Proc Tabulate and Proc Summary.
• Created new tables and manipulated data by using various joins and merges and then appended the data (Proc append) from the existing source tables containing millions of records.

Confidential, Thousand Oaks, CA

Clinical Trials SAS Programmer

Responsibilities:

• Data imported by using SQL passes through facility and proc import.
• Used SAS Proc SQL created SAS datasets using various SQL joins such as left join, right join, inner join and full join.
• Clean and validate the data.
• Involved in writing the code using base SAS and macros.
• As per SAP created tabular reports using base SAS and SAS /reports procedures.
• Generated analysis reports using SAS /reports.
• Producing tables as per the analysis specifications.
• Generated the reports or data files and tables as required and delivered them on time to the requestor.

Confidential

SAS Programmer

Responsibilities:

• Extracting data from different sources where information is stored in Excel and text/CSV files using SAS/SQL in SAS environment and creating SAS files.
• Performing data validation, data cleaning, and transposing data using different procedures (PROC MEANS, PROC FREQ, PROC SORT etc.) and statements (KEEP, RENAME, OBS, FIRST, PUT, FORMAT etc.)
• Merging SAS datasets using various SQL joins such as LEFT JOIN, RIGHT JOIN, INNER JOIN and FULL JOIN as well as using SAS procedures such as SET, MERGE, and PROC APPEND etc.
• Performing advanced analytics and analyzing data using different SAS and SQL procedures such as PROC UNIVARIATE, PROC SUMMARY, PROC FREQ etc.
• Creating analytical reports (periodic and ad-hoc) for different reports using PROC REPORT, PROC TABULATE, PROC SUMMARY, ODS statements and generating outputs in HTML, Excel and RTF formats
• Developing SAS Macro programs and using macro functions (%LET, CALL SYMPUT, %NRSTR, SYMGET etc.) to automate reporting process to improve process efficiency and provide more meaningful information vital to the overall strategies
• Created new tables and manipulated data by using various joins and merges and then appended the data (Proc append) from the existing source tables containing millions of records.
• Review and modify SAS Programs, created customized ad-hoc reports, process data for publishing business reports; automate and distribute designed business reports on schedule in various format.
• Customizing the existing Macros according to the need and requirement, testing and debugging the Macros and creating more complex and reusable Macros.