SUMMARY

• SAS professional with over 7 years of experience with analysis and reporting of healthcare and clinical trials data.
• Successfully fulfilled and involved in all phases of System Development Life Cycle (SDLC) including gathering requirements, creating specifications, developing codes, validating and maintaining programs.
• Facilitated reporting on patient care quality through providing SAS Programming and administrative support for Healthcare Effectiveness Data and Information Set (HEDIS) submissions using Data Step, SAS Macro, and Proc SQL to perform data manipulation, quality checks on results, and reporting.
• Knowledge of IHHS, CBAS, and supplemental health benefits.
• Strong exposure to SAS programming for Clinical Study Report (CSR), Integrated Summary of Safety (ISS), and Integrated Summary of Efficacy (ISE).
• Extensive experience reviewing study protocols, Case Report Forms (CRFs), Statistical Analysis Plans (SAPs), and dataset specifications for Phase I - IV clinical trials.
• Through knowledge and experience in creating and validating CDISC SDTM and ADaM datasets.
• Developed metadata specifications for SDTM datasets based on annotated CRFs and created SDTM datasets as per specifications.
• Created and validated ADaM datasets such as subject-level dataset, Basic Data Structure (BDS) datasets, and other datasets along with specifications.
• Provided input to the mock-shells and programming specifications for multiple clinical trials.
• Participated in the SAS programming efforts generating and validating Tables, Listings and Graphs (TLGs) as per specifications.
• Generated customized reports using standard company macros and Proc Report procedure.
• Supported time-sensitive ad-hoc requests addressing questions from regulatory authorities.
• Strong experience with SAS Base, SAS SQL, SAS Macro, SAS ODS, SAS Graph, SAS Stat tools and SAS EBI.
• Extensive experience with various data management and reporting tools in the healthcare and pharmaceutical industry.
• Therapeutic area of expertise: Oncology, Pain, Cardiovascular, Virology and.
• Self-motivated, capable of working independently as well as in a fast paced team environment.

TECHNICAL SKILLS

Operating Systems: Windows, UNIX, Linux

Database: MySQL, MS-Access, Oracle, SQL Server, DB2, MS Access

Statistical Packages: SAS, Excel

SAS Tools: SAS/BASE, SAS/SQL, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/CONNECT, SAS/ACCESS, SAS/Enterprise Guide, SAS/Connect, SAS/EBI

SAS Procedures: Compare, Export, Format, Freq, Gplot, Import, Lifetest, Logistic, Means, Phreg, Mixed, Print, Sql, Sort, Summary, Tabulate, Transpose, Report, Univariate

PROFESSIONAL EXPERIENCE

Confidential, VA

Sr. SAS Programmer

Responsibilities:

• Supported SAS Programming activities for membership and claims data and involved in software development life cycle of the project.
• Provided SAS programming support for HEDIS data deliverables.
• Use LIBNAME and SQL PASSTHRU facility to read data from other sources.
• Use SAS/ACCESS to read datasets from Databases, Flat files, also read and write other PC File formats.
• Perform extraction, transformation and loading from large Oracle tables.
• Manipulate existing Oracle database by accessing the data using SQL pass through facility.
• Work on pre-existing macros for data validation by checking data distribution and comparison to standard data.
• Perform data cleansing by analyzing and eliminating duplicate and inaccurate data using proc freq, proc univariate and macros in SAS
• Create new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, and conditional statements.
• Validate, document and test component programs in an efficient manner for inclusion in integrated reports.
• Develop, analyze and design SAS programs in UNIX platform.
• Generate highly customized reports in the form of listing, HTML, RTF and PDF using SAS ODS, PROC REPORT, PROC TABULATE, and PROC SQL.
• Involve in discussions with business users and data architects to define metadata for tables to perform ETL process.
• Involve in developing, testing, and writing programs and reports in SAS according to specifications as required.

Confidential, Fort Washington, PA

Sr. Statistical Programmer

Responsibilities:

• Experience working in Phase I- III clinical trials.
• Participate in study-related activities such as review of case report forms, output specifications and dataset specifications.
• Extensive programming in different safety domains such as Laboratory data, Adverse Events, Concomitant Medications, Vital Signs, Time to Event for Safety analysis.
• Created multiple protocol deviation and on-study listings to assist medical team review.
• Experience working on regulatory submissions such as ISS/ISE.
• Worked on preparing and validating datasets for PK/PD analysis.
• Created SAS macros for reporting of the multiple tables across studies and for the similar tables for subgroup analyses.
• Modify/Validate existing SAS macros to report summary as well as descriptive statistics
• Provided programming support for Ad-hoc analysis and reports.

Confidential, NC

SAS Programmer

Responsibilities:

• Created SAS programs to generate derived/analysis datasets, data listings, summary tables and annotated figures.
• Provided programming support, utilized and modified standard programs to generate reports in compliance with SOPs.
• Performed data manipulations using SAS DATA steps and Proc SQL ensuring efficient program logic.
• Created figures consisting of Plots using Gplot.
• Created TLFs for demographics, patient disposition, adverse events, serious adverse events, laboratory parameters, protocol violations, vital signs, ECG parameters and efficacy endpoints as per SAP.
• Performed program validation using independent programming.
• Participated in the study-related activities such as review of draft TLFs, protocol violations, consistency between results presented in clinical study reports (CSR) and validated TLFs.
• Provided programming support for Ad-hoc analysis and reports.