SUMMARY

• Over 6+ years of experience as a SAS programmer in Clinical trials and Health care data analysis in Phase I - IV.
• Expertise in SAS programming features like SAS/BASE, SAS/MACROS, SAS/ STAT, SAS/ACCESS, SAS/GRAPH, SAS/CONNECT, SAS/SQL, and SAS/ODS both on Windows and UNIX platforms.
• Proficiency in generating reports featuring various SAS procedures, like null, ODS, Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort, Proc Univariate, and Proc SQL.
• Experience in using SAS to read, write, import and export to another data file formats, including delimited files, Spreadsheets, Microsoft Excel and Oracle databases.
• Experience in cleaning and resolving data issues and merging data from various data sources into a single dataset.
• Excellent knowledge in creating various global and local macro variables.
• Experience in using SAS programming in analyzing the Clinical Trial Data and responsible for generating tables, listings and graphs (TLGs).
• Strong academic background in drug development process-conducting clinical trials, collection (paper CRF, eCRF (EDC), analyses, presentation of data and in understanding Code of Federal Regulations (21CFR) Part 11, GCP, ICH, FDA and other regulatory guidelines.
• Strong working knowledge in CDISC, WHO Drug dictionary and MedDRA regulated environment.
• Extensive experience in creation of SDTM datasets and in derivation of ADaM datasets by implementing CDISC Standards.
• Good command on ODM and Define.XML.
• Working Knowledge in Integrated Summaries of Efficacy (ISE) and Integrated Summaries of Safety (ISS) according to Statistical Analysis Plan (SAP) and Protocol.
• Excellent knowledge in data flow from Raw Datasets/DM Datasets to creation of submission package i.e. CRT packages.
• Self-motivated, team-player and goal-oriented professional with excellent communication skills.
• Therapeutic Areas: Oncology, Neurology, Central Nervous System (CNS), Virology.

TECHNICAL SKILLS

SAS Tools: SAS Base, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS/CONNECT.

SAS Procedures: Univariate, GLM, Logistic, Lifetest, Freq, Summary, Means, Gplot, Gchart, SQL, Append, Sort, Format, Import, Export, Transpose, Report, Datasets, Catalog.

Databases: MS Access, Oracle Clinical, MS Excel.

Operating systems: Windows, UNIX.

Others: MSOffice, SQL, Core JAVA, HTML.

PROFESSIONAL EXPERIENCE

Clinical SAS Programmer

Confidential, Stratford CT

Responsibilities:

• Participated in the SAS programming for multiple clinical trials and ISS/ISE.
• Successfully handled lead programmer responsibilities including gathering requirements, creating specifications, developing codes, validating and documenting programs.
• Created/validated CDISC SDTM and ADaM compliant datasets along with its metadata specifications.
• Reviewed and provided comments for statistical analysis plans and specifications for the mock shells.
• Combined data from multiple studies to create pooled datasets for reporting of ISS/ISE.
• Created standard Safety tables for Adverse Events, Concomitant Medications, Electrocardiograms, Vital Signs, and Labs.
• Generated shift tables, change from baseline tables, and outputs for Efficacy Endpoints.
• Created SAS macros for reporting of the multiple tables across studies and for the similar tables for subgroup analyses.
• Coordinated work on multiple studies simultaneously as per priorities and met all study timelines.
• Produced annotated Survival Curves.
• Provided programming support for Ad-hoc analysis and reports.

Environment: SAS 9.3,SAS/BASE,SAS/SQL, SAS/MACRO,SAS/GRAPH, SAS/ODS, SAS/ACCESS, MS Excel.

Clinical SAS Programmer

Confidential, Pleasanton, CA

Responsibilities:

• Validated source and analysis datasets using SAS procedures and standard macros.
• Dealt with large blood screening lab data (external and internal) review and analysis.
• Generated/ Validated Tables, Listings, and Graphs using different SAS procedures.
• Recommended technical and process solutions that can be used or developed to increase efficiency of project work.
• Adapted to changing circumstances, policies, work assignments, and/or team members.
• Worked multiple studies at same time and deliver them on time.
• Prioritized and delegated tasks based on the importance of the deliverable and awareness of overall timelines in order to efficiently produce high quality deliverables.

Environment: SAS 9.3,SAS/BASE,SAS/SQL, SAS/MACRO,SAS/GRAPH, SAS/ODS, MS Excel.

Clinical SAS Programmer

Confidential, WA

Responsibilities:

• Contributed in study-related activities such as review of CRF, and SDTM and ADaM specification document.
• Reviewed edits check specifications to ensure data accuracy and data validity/integrity.
• Created, analyzed and summarized safety and efficacy SDTM and ADaM dataset associated with clinical studies, as per the specifications in the SAP (statistical analysis plans) at study-level and project-level.
• Performed statistical analysis of efficacy endpoints using various SAS procedures such as Univariate, Freq, Glm, Mixed, Logistic, and Lifetest.
• Generated TLGs using ADaM datasets, programming specification documents, SAP and TLG shells.
• Create customized figures for clinical study reports as well as ad-hoc requests using SAS procedures Gplot and Gchart.
• Generated CRT packages and validated them for FDA submission.
• Modified/validated existing SAS macros to report summary as well as descriptive statistics.
• Performed validation of SAS programs and standard macros using company guidelines and communicated findings to the programmer/ biostatistician.

Environment: SAS 9.2-9.3,SAS/BASE,SAS/SQL, SAS/MACRO,SAS/GRAPH, SAS/ACCESS, SAS/ODS, MS Excel.

SAS Programmer

Confidential, MI

Responsibilities:

• Utilized SAS Procedures and otherSAS applications for data updates, data cleansing and reporting.
• Identified and correct data step syntax and programming logic errors.
• Efficient in using data step programming to solve complex programs.
• Import and Export of clinical data across a variety of applications to and from SAS.
• Validated of programs and processes to extract data from Clinical data management systems, to prepare data listings, summary tables and reports using SAS.
• Provided data verification and problem resolution as and when required.
• Produced external files and reports employing variousSAS procedures.

Environment: SAS 9.2,SAS/BASE,SAS/SQL, SAS/MACRO,SAS/GRAPH, SAS/ODS, MS Excel.