SUMMARY:

• Sr. SAS Programmer with 8 Plus years of experience supporting Statistical programming projects in Contract Research Organizations and Pharmaceutical Companies.
• Experienced in Integrating Data from multiple studies and sources.
• Extensive experience in all phases Phase I to III of clinical trials: Analyzing clinical data, creating tables, listing and generating reports and graphs.
• Experienced in working with SDTM and ADAM datasets. Also involved in writing specifications.
• Highly skillful in Clinical Trials Data like Demographic data DM , Adverse Events AE , Laboratory data Lab data , Vital Signs etc.,
• Involved in Transport file creations for e-Submission.
• Involved in Clinical Data Analysis and preparation of SAS Datasets, reports, tables, listings, summaries and graphs according to the Standard Operating Procedures SOPs and GCP guidelines.
• Generating Safety and Efficacy tables, data listings and graphs
• Good understanding of CRF Annotation, ICH , 21CFR part 11 guidelines, FDA regulations, WHO drug, MedDRA dictionaries
• Experience with Data Validation, designing Edit check programs and parallel development of tables listings for project level programs.
• Demonstrated proficiency in CDISC Mapping, NDA Submissions, Validation Systems, Statistical Analysis, ISS, Output Delivery System ODS , Ad-Hoc Listing/Reports, SAS Data Steps, SAS Macros, Graphing, Summarizing and Reporting procedures.
• Proficient in handling multiple projects and excellent analytical and problem solving skills.

PROFESSIONAL EXPERIENCE:

Confidential

Sr. Statistical Programmer

• Mapping and integrating external study data to a CDISC-compliant proprietary analysis data system
• Create datasets according to CDISC SDTM and ADAM standards.
• Involved in QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents
• Developing files for electronic submissions to regulatory agencies
• Performed validation on derived datasets and following the standard operating procedures during validation procedures
• Worked on ISS and ISE including analysis data sets, tables, listings and graphs as per the SAP
• Involved in planning, writing and executing statistical programs designed to analyze data
• Ability to write some common macros that are useful across multiple studies
• Established domain models according to SDTM specs and also created new domains that are CDISC compliant and Implemented CDISC SDTM Standards.
• Involved in creating Transport-files for electronic submissions to FDA.
• Performed ad hoc programming as per client's requests.
• Produced high quality graphs through SAS/GRAPH for analysis.
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Developed specs to map a clinical study in compliance with SDTM 3.1.2 and annotated CRF accordingly.
• Assisted with development, implementation, maintenance, and user support of programming tools and process methodology within the Statistical Programming department.

Confidential

SAS Programmer

• Develop and maintain programs to meet internal and external client's needs
• Responsible for providing proper validation, including testing and documentation in accordance with company standards
• Participate in the design and maintenance of a standard programming environment
• Used SAS Macros extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables
• Developed Tables, Listings and Figures for various on-going studies
• Used company defined macros extensively to standardize programs and make the code reusable
• Maintained and updated existing utilities as per project requirements.
• Used department macros for report generation.
• Active involvement in knowledge sharing via presentations at monthly programming meetings.
• Involved in generating TLG's for Integrated Summaries of Efficacy ISE and Safety ISS for FDA submission.
• Resolved issues with datasets, tables and listings to the satisfaction of lead and senior biostatisticians.
• Performed the edit checks as necessary.
• Communicated with Statisticians about various analysis dataset and TLG specification related issues.
• Managed the clinical trial project organize timelines, responsibilities and deliverables .
• Created and validated Analysis datasets, Tables, Figures, and Listings according to the Statistical Analysis Plan SAP
• Perform ADHOC programming per regulatory and statistician requests.

Confidential

SAS Programmer

• Responsible for providing SAS programming and analysis support for phase III clinical study
• Involved in e-submissions by creating Annotated CRFs, and Transport datasets in .XPT format
• Developed Tables, Listings and Figures using PROC REPORT
• Interacted with statistician and clinical people for creating reports
• Experience in providing tables and figures to be incorporated into Clinical Study Report along with patient data listings and technical statistical details such as derivations, computations, analyses etc and also involved in discussions with medical writers in the preparation of Clinical Study Report
• Formatted HTML, XML, ASCII, CSV, EXCEL, PDF and RTF reports, using SAS - Output Delivery System ODS .
• Interacted with other databases using SQL PASS THROUGH FACILITY.
• Involved in coding analyzing, Report generation and testing programs using SAS/Base, SAS/Macro, SAS/Stat and SAS/SQL according to the client requirement
• Performed quality controls QC on SAS programs.
• Documented all project data flows and programs.
• Responsible for implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity

Confidential

SAS Programmer

• Responsible for providing SAS programming and analysis support for phase III clinical study
• Involved in e-submissions by creating Annotated CRFs, and Transport datasets in .XPT format
• Developed Tables, Listings and Figures using PROC REPORT
• Interacted with statistician and clinical people for creating reports
• Experience in providing tables and figures to be incorporated into Clinical Study Report along with patient data listings and technical statistical details such as derivations, computations, analyses etc and also involved in discussions with medical writers in the preparation of Clinical Study Report
• Formatted HTML, XML, ASCII, CSV, EXCEL, PDF and RTF reports, using SAS - Output Delivery System ODS .
• Interacted with other databases using SQL PASS THROUGH FACILITY.
• Involved in coding analyzing, Report generation and testing programs using SAS/Base, SAS/Macro, SAS/Stat and SAS/SQL according to the client requirement
• Performed quality controls QC on SAS programs.
• Documented all project data flows and programs.
• Responsible for implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity

Confidential

SAS Programmer

• Worked mainly on phase II and Phase III studies.
• Created various datasets in accordance with the specifications mentioned.
• Involved with various data review meetings.
• Extensively created various Analysis datasets as per required specifications developed using mock shells and SAP Statistical Analysis Plan .
• Performed QC validations for various datasets and TLG's by parallel programming.
• Worked on various PK merge files.
• Created various Ad-hoc reports as required by statistician and FDA.
• Created various reports using standard reporting macros project specific , as well as using data null .
• Actively participated in ISS/ISE integration for various studies.
• Created several transport files .xpt using Proc copy for Define.pdf document.
• Good working experience on MACROS i.e., Modifying the standard macros, developing study specific macros and as well as implementing various macro debugging options.
• Performed documentation for various programs so as to make the program self-explanatory.