SUMMARY:

• Sr. SAS Programmer with 8+ years of experience with emphasis on analysis, development, testing and implementation of various projects for Pharmasuitical and CRO industries.
• Strong knowledge involving in all (I,II,III) phases of clinical studies.
• Excellent experience in implementation of the CDISC standards - SDTM and ADAM.
• Expertise in analyzing and coordinating clinical trail data, generating reports, tables, listings and
• Knowledge of different data domains such as demographics (DM), concomitant medications (CM), Exposure (EX), vital signs (VS), lab (LB), adverse events (AE & SAE) medical history (MH) and protocol deviations(DV).
• Experience in extracting the data from Oracle and SQL Server databases efficiently.
• Strong knowledge in SAS/BASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS/CONNECT.
• Experience in writing/customizing macros to develop concise and reusable code.
• Excellent command in producing reports employing various procedures like Proc SQL, Proc REPORT, Proc TABULATE, Proc SORT, Proc TRANSPOSE, Proc UNIVARIATE, Proc SUMMARY etc.
• In-depth knowledge of SAS programming, data processing, data collection, quantitative and qualitative data analysis.
• Good knowledge on CDISC SDTM Specifications.
• Experience in CDISC (SDTM) mapping from raw datasets.
• An excellent knowledge in submission of data in CDISC SDTM format, based on CDISC SDTM Implementation guide (SDTM IG).
• Good knowledge on CDISC SDTM standards and on using Open CDISC validator to check the compliance of the SDTM datasets.
• Provide programming support in generating and\or validating analysis datasets (SDTM and ADaM).
• Created, Validated and executed Tables, Listings, Graphs (TLGs) and analysis data set programs of both Safety and Efficacy.
• Knowledge of ISS (Integrated Summaries of Efficacy) and ISE (Integrated Summaries of Safety) as per specifications.
• Working knowledge in the CDISC and MedDRA regulated environment.
• Excellent skills in statistical analysis and problem solving, familiar with common statistical methods for clinical research and Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures, Protocols of clinical trials.
• Good Knowledge of Clinical Terminology and Regulatory Guidelines.
• Excellent hands on preparation of Clinical study Report.
• Tharough in doing edit checks, validation of analysis data sets, tables and listings.
• Involved in e-submissions and creating Annotated CRF.
• Experienced in handling / working on multiple projects and studies.
• Ability to work effectively both as an individual and in local/global teams.
• Excellent written and verbal communication skills.
• Quick learner and hard worker.

TECHNICAL SKILLS

SAS: Base SAS 9.1/9.2.9.3, SAS/MACRO, SAS/SQL, SAS/ACCESS, SAS/STAT.

Environment: Windows XP, UNIX.

​Office tools: MS-Office Suite, Ultra edit.

Database: Oracle, SAP.

PROFESSIONAL EXPERIENCE:

Confidential, Waxhaw, NC

Sr. SAS Programmer

Responsibilities:

• Understanding the requirements of the application.
• Worked on phase II and III clinical studies with specific end points.
• Created analysis data sets, tables, listings and plots according to the specification of the study for statistical analysis.
• Created analysis datasets based on the guidelines provided in the Data Definition Tables (DDT) and following the CDISC standard. Used SDTM/ADaM for domain creation and CDISCcompliant analysis datasets.
• Data validation and quality contole check of the displays and data sets according to the different QC guidelines and independent programming.
• Intigrated data from multiple studies for creation of ISS and ISE as required .
• Implementing CDISC SDTM and ADAM guidelines according to the provided specificatios.
• Creation of CDISC specifications for Findings, Events domain.
• Involved in generation of TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Developed Macros for replacing repetitive codes and used organization provided macros.
• Involved in creation of transport files for Submission.
• Developing efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/ Base and SAS/ Macro facility.
• Supported the team with validation including program validation and independent programming.
• Maintained and updated existing utilities as per project requirements.
• Involved in building format libraries for different studies.
• Actively participated in meetings, gave presentations and involved in knowledge sharing.

Confidential, Rockville, MD

Sr. SAS Programmer

Responsibilities:

• Reviewing and evaluating the clinical research related programs (Phase I and Phase II data of Clinical Trials).
• Programming of data listings and data validation tools using SAS.
• Involved in preparing, developing data, analyzing, coding, report generation and testing programs according to the specifications and client’s requirements.
• Creating tables, listings and grphs for inclusion in clinical study reports and regulatory submissions.
• Created the desired Tables, Figures, and Listings according to the Statistical Analysis Plan (SAP) and following the directive of the Programming Manager.
• Performing the verification of SAS-generated outputs (tables, listings and graphs).
• Reviewing mock tables, listings, analysis dataset specifications and provided feedback to concerned statisticians.
• Integrating data from multiple studies for ISS and ISE.
• Implementing CDISC SDTM Standards.
• Involved in creating Transport-files for electronic submissions to FDA.
• Producing high quality graphs through SAS/GRAPH for analytical purposes.
• Developing routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions; and maintaining existing ones.
• Assisting the Manager of Programming by validating, researching, and implementing new software and programming processes.
• Assisted the development, implementation, maintenance, and user support of programming tools and process methodology within the Statistical Programming department.

Confidential, KS

Responsibilities:

• Involved in preparing analysis plan, data analysis and statistical report.
• Frequently used PROC TABULATE, PROC REPORT, PROC SUMMARY and PROC FREQ.
• Understood importance of validation (verification/documentation) process in compliance with regulations and policies.
• Producing the data listings, summary tables and graphs for interim and final analysis and publications.
• Providing data in SAS transport files, and other appropriate deliverables and documentation for regulatory submissions.
• Performing the validation programming on clinical trial data using SAS MACROS.
• Created base macros to run reports and used organization provided macros.
• Creating standard reports to use across studies and creating base programs to set up data.
• Using SAS for the pre-processing of data, data analysis, generating reports, statistical analysis, and graphs.
• Performing quality control (QC) analysis on SAS programs.
• Documenting and organizing all project data flows and programs.
• Responsible for implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity.

Confidential, NJ

SAS Programmer

Responsibilities:

• Analyzed the clinical trial data for Phase I, II and III study.
• Created analysis data sets and TLF’s by using SDTM/ADaM datasets.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools - SAS/Base, SAS/MACROS, SAS/Graph, SAS/SQL, and SAS/STAT etc.
• Produced data listings, summary tables and graphics for interim and final analysis.
• Written MACROS to replace repetitive codes for generating Descriptive statistics.
• Created SDTM domains from raw datasets as per CDISC standards.
• Created ADaM datasets from the SDTM domains and generated TLGs.
• Performed Data Validation and Data Cleaning on Clinical data using procedures like PROC Freq, PROC Means, and PROC Univariate.
• Worked with statistician to analyze the results obtained from various statistical procedures like PROC ANOVA.