- SAS Programmer/Analyst with over 8 years of experience in using SAS for analysis, development, and validation of various projects for CROs’, Pharmaceutical and Health Care Industries.
- Familiarity with ICH-GCP guidelines, Healthcare data and terminology, and electronic submission standards.
- Created Tables, Figures, and Listings (TLF’s) according to the Statistical Analysis Plan (SAP) and specifications.
- Experience in reviewing and annotating the study case report forms (CRF) from CDISC perspective.
- Performed data mapping to generate SDTM and created derived datasets in compliance with CDISC SDTM and ADaM standards and estimated survival analysis from Kaplan Meier Curves using PROC LIFETEST.
- Worked on define.xml for NDA submission of SDTM datasets, CRT’s and metadata files to FDA and regulatory authorities following the guidelines set by CDISC.
- Thorough knowledge of Clinical Trials data like Demographic data, Vital Signs, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data and Efficacy related data.
- Proficient in understanding of Study Protocols, SAP, DMP, SOP, CRT (Item 11), MedDRA, NDA, IND, 21CFR Regulations for regulatory submissions.
- Performed Cleaning, Coding, QC and creating Validation & Derivation procedures (edit checks) as per protocol designs on Clinical Data.
- Collaborated with CROs (Contract Research Organizations), LABs, and technology vendors in managing data flow and to resolve any issues that arise from invalid data.
- Developed Programming specifications for multiple data transfers, and protocol specifications with the help of biostatistician to meet future needs according to CDISC standards.
- Experience in programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
- Had good understanding of data acquisition, management, data mining and data warehousing.
- Knowledgeable in various Phases of clinical trials from Phase I-IV, and had experience in setting-up clinical studies in Oracle Clinical (character layout and PDF layout).
- Extracted data from the clinical database, Oracle and Teradata using SAS/ACCESS SQL Pass-Through Facility and LIBNAME statement, and prepared customized analysis datasets for specific reporting needs.
- Generated Safety and Efficacy tables and created reports, data listings and graphs for NDA submissions.
- Experienced in validating programs using SAS MACROS, and to generate listings and tables for CSR.
- Experienced in exporting reports in HTML, RTF and PDF formats using ODS statements.
- Collaborated with Statisticians, DBM, Medical Writers, Investigator, and Clinical Research Associates to complete scientific reports and reviewed reports to ensure accuracy and clarity.
- Excellent presentation skills with ability to discuss the statistical aspects of clinical trials.
- Always emerged to be an excellent team player with strong leadership skills.
- Had good understanding of System Development Life-Cycle (SDLF) and Testing (unit, system and UAT).
- Operating System: Windows 98/2000/XP/NT and Sun -Solaris UNIX.
- Database: Oracle Clinical, Clin-trial, Sybase, DB2, Teradata and MS Access.
- SQL Queries: PROC SQL, SQL
- SAS Skills: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/SQL, PL/SQL, SAS/GRAPH, SAS/ODS, SAS/ACCESS, SAS/GCHART, SAS/CONNECT, SAS/ASSIST, SAS/ETL, SAS/ENTERPRISE GUIDE.
- SAS Procedures: PRINT, MEANS, REPORT, SORT, FREQ, TABULATE, TRANSPOSE, IMPORT, EXPORT, SQL, COMPARE, REG, CORR, ANOVA, ANCOVA, GRAPH, GPLOT, GCHART, LIFETEST, UNIVARIATE, and Kaplan Meier Curve.
- Tools: MS-office, MS Visio, VB, VBA, SPSS.
Confidential , IL
Sr. SAS Programmer – Clinical
Summary: As a SAS Programmer, I was involved in Phase 2 clinical trials in Infectious disease domain, evaluating the drug safety, efficacy, and tolerability by generating reports, creating Tables, Figures, and Listings for analysis according to the Statistical Analysis Plan (SAP) and specifications required for submission to FDA.
- Reviewed Protocol, SAP, DMP, SOPs, CDISC standards and eCRF layout.
- Created Analysis Datasets, TLF’s as primary programmer and validated as a secondary programmer.
- Extensively used PROC SQL to clean and validate data for the ad-hoc reports.
- Reviewed SDTM specification and ADaM specification and annotated eCRF according to SDTM variables.
- Created SAS programs for SDTM mapping of raw datasets.
- Applied concatenating, merging, and appending techniques to SAS datasets using data step SET, MERGE, PROC SQL and PROC APPEND.
- Conducted SAS multivariable statistical analysis to generate reports using different procedures such as PROC Report, FREQ, and TABULATE and SAS Enterprise Guide.
- Compared data structures, formats and variables using Proc Compare and Macros.
- Worked on define.xml for NDA submissions.
- Accessed the internal database Oracle, Teradata using SAS/Access SQL Pass-Through facility and LIBNAME.
- Developed and documented SAS programs and macros for Validation and Audits
- Collaborated with statisticians and Data management team to locate and resolve queries.
- Developed and modified SAS programs and supported lead programmer in electronic submissions to NDA.
Environment: SAS 9.2, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, SAS/EG, UNIX, Windows.
Confidential , CT
Summary: Involved in writing codes for SAS programs to extract health insurance claims data, health care operational data from various data sources and analyzing health insurance claims or clinical data using statistical methods.
- Involved in storing, reporting and managing data, developed SAS Procedures, Macros, and applications for data cleansing, reporting and documentation.
- Performed debugging SAS code, compiling errors, reviewed SAS code and quickly identified areas of concern.
- Created reports in EXCEL, PDF, CSV files for Healthcare Reporting.
- Performed data cleansing, transformation, aggregation, and summarization.
- Investigated data quality issues and research data (business logics, any transformation being done) for accuracy.
- Integrated data from large relational databases using SQL and SAS tools and procedures.
- Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access.
- Produced quality customized reports and created figures using SAS/Enterprise Guide, GPLOT and GCHART.
- Accessed the internal database Oracle using SAS/Access SQL Pass-Through Facility and LIBNAME statement.
- Familiar with healthcare data and terminology.
- Developed general-purpose and ad hoc SAS programs/Macros for validation, analysis, and reporting.
- Analyzed existing processes and replaced them with more efficient processes.
Environment: SAS 9.2, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, SAS/ETL, Teradata, Windows.
Confidential , CA
SAS Programmer – Clinical
Summary: As a SAS programmer, my role was in analysis of Clinical trial data in Oncology domain, and generating required reports, listings, tables and Graphs for submission to FDA and other regulatory authorities.
- Created and updated input documents for essential macros of the study (such as titles and foot notes).
- Modified the utility macros and created various Local and Global Macros as per the study requirement.
- Performed statistical analysis, wrote SAS code for data management and reporting, and performed validation, including testing SAS code.
- Developed reports using PROC REPORTS, PROC TABULATE and DATA NULL .
- Developed efficient, well documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility.
- Provided programming expertise in raw data mapping in compliance with CDISC Standards and the generation of data listings, summary tables and graphs for interim and final analysis.
- Ensured analysis data and programming code meet regulatory and company standards and were consistently structured to permit efficient programming and reporting.
- Created DDT (Data Definition Tables) for NDA submission.
- Created graphs by using the SAS annotate facility and SAS/GRAPH procedures.
- Generated numerous ad-hoc reports on routine basis.
- Accessed various database to gather data, performed a table lookup and translated data values for readability.
- Downloaded data from Oracle and Teradata, using SQL Pass-through facility within SAS to be analyzed and exported to Excel from SAS using IOM, VBA, ADO/OLE DB and SAS Objects for further analysis.
- Involved in clinical trials programming of data tables and listings for reporting on safety and efficacy.
Environment: SAS 7/8, SAS/SQL, SAS/BASE, SAS/MACROS, Teradata, Oracle 8, VBA, UNIX and Win. NT
Confidential , PA
Summary: Confidential is a leading CRO, offering a complete range of preclinical and clinical services to the pharmaceutical, biotechnology, and medical device industries. As a SAS programmer, I was involved in different Phase I to Phase III studies.
- CDISC SDTM Experience - mapping of various phases of clinical trial data into the SDTM format.
- Converted different formats of external data files into SAS datasets, such as Excel, Access and DB2 by using Proc format, Proc Import and SAS/Access.
- Developed, modified, validated and implemented SAS programming work according to Statistical Analysis Plan.
- Prepared efficacy and safety summary results with tables, listings, graphs and reports for NDA submissions.
- Extracted data from Oracle data base by using SQL Pass-through facility and Libname.
- Involved in the development of clinical trial data tables – Demographic, Adverse Events (AE), and Serious Adverse Events (SAE) and Laboratory data tables.
- Prepared analysis datasets and graphical plots to support ad-hoc requests.
- Created edit check programs to check data issues and make sure data is consistent with previous data transfer.
- Created integrated datasets for ISS and ISE analysis and created table, listing and graphs for ISS and ISE.
- Responsible for generating and validating specifications, SDTM domains, ADaM, tables/listings/figures.
- Developed DDTs for programming the analysis datasets according to CDISC and study specifications in coordination with study Biostatistician.
- Built complete format libraries for various studies.
- Ensured that analyzed data and programming code met regulatory and company standards and were consistently structured to permit efficient programming and reporting.
- Carried out all activities according to SOPs, SAP, and DMP working within the framework of the Quality Management System, GCPs and GPPs.
- Created reports using PROC REPORT for Adverse Events and Laboratory results as a part of safety measurement in RTF, and PDF style formats using ODS statements and SAS 9 enhancements.
Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, Windows, Excel, Oracle.
Confidential , India
Summary: Confidential is one of the reputed referral companies in India and is involved in the research and treatment of Cardiovascular and Central Nervous System Disorders. As a junior Statistical programmer, I was involved in the study and design of Clinical trials.
- Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access.
- Prepared reports based on the requirements using PROC REPORT, PROC TABULATE, PROC PRINT and DATA NULL for Adverse Events, Demographics, Lab, and Vital signs.
- Proficient in drawing flowcharts indicating the input data sets, and the output files.
- Coded using SAS/BASE and SAS/MACROS to extract, clean and validate data from oracle tables.
- Created, maintained and reused SAS Macros to consolidate and streamline table writing routines.
- Validated tables, listings, and graphs using a variety of methods, including independent programming, Debugger, Put statements and visually checking numbers against data sets.
- Performed documentation on all programs, files and variables for validation and future references .
- Created various ad-hoc reports as per statistician’s request.
- CRF Tabulation Dataset creation from clinical trial data with MedDRA terms for regulatory submissions.
- Provided programming for creating Pooled database for ISS and ISE.
- Performed QC, Data Validation and Edit Checks using various procedures and Macro facility.
- Created analysis datasets based on the guidelines provided in the DDTs.
Environment: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/STAT SAS/GRAPH, SAS/ACCESS, Oracle 9, Windows.