- SAS Programmer with 6+ years of professional experience in Clinical Trial projects and SAS Programming in the CROs, Healthcare and Pharmaceutical industries.
- Experience in analyzing and coordinating clinical data, generating detail summary reports and data validation using FDA regulation procedures.
- Extensively involved in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to the Standard Operating Procedures (SOPs).
- Good experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, and SAS/ODS, SAS/QC, SAS/AF and SAS/ETS on Windows and UNIX environment.
- Proficient in Macro Facility, SAS Procedures, SAS formats, SAS functions, SAS statements, SAS Informats, Merging SAS Data sets, preparing data, producing reports, storing and managing data in SAS.
- Good in modifying existing SAS programs and creating new programs using SAS macro variables to improve ease and speed of modification as well as consistency of results.
- Working with large volume data warehouses and data access tools (Windows, UNIX, etc.).
- Validating, testing, debugging SAS code to determine quality, completeness, and accuracy per specifications.
- Creating appropriate (business/technical) documentation for all the programs developed.
- Exposed to health claim coding systems.
- Analyzed data sources for integrity, precision, and accuracy.
- Proficient in working with different clinical trials data like Demographic, Adverse Events (AE), Laboratory, Vital Signs etc.
- Involved in the process of generating TLG’s (Tables, Listings and Graphs) for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
- Proven skills in data cleaning, data archival, data migration, ad-hoc reporting and coding using SAS on various environments.
- Good in performing CRF–Annotation with respect to various database designs.
- Experience in Compliance Reports including IND submissions and NDA Documentation, developed as per QC/QA protocols and FDA guidelines.
- Knowledge in conducting, documenting and reporting computer validation inspections in compliance with 21CFR Part 11 (21 Code of Federal Regulations) for clinical trial systems.
- Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM), Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification (Define.xml).
- Have excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels of the organization and contributing to project success in multi-tasking, fast paced environment.
Technical Skills:SAS TOOLS: SAS9. , SAS/BASE, SAS/MACROS, SAS/STAT,
SAS/GRAPH, SAS/ODS, SAS/SQL, SAS/QC
SAS PROCEDURES: SORT, CONTENTS,TRANSPOSE,GPLOT, GCHART, FREQ, MEANS, SQL, REPORT, TABULATE, PRINT, PRINTTO, GLM, SUMMARY, REG , CORR, UNIVARIATE, CDISC,LIFETEST, PHREG,
Operating system: Windows98/2000/XP, Unix
Database: MS Access, SQL Server 7.0,oracle 9i
Confidential, April 2010 – Present
(Formerly Omnicare Clinical Research)
Role: Sr.SAS Clinical Programmer
The studies I was involved included a Phase-II clinical trial to evaluate number of small molecules that selectively inhibit the translation of the hepatitis C virus protein without inhibiting human host cell translation. As a SAS programmer my role was assisting the statisticians in analyzing clinical trial data and generating required reports, listings, summaries and graphs.
- Extracted data from flat files, MS Excel, and Oracle Clinical database, created SAS data sets using different SAS procedures and SAS/SQL “Pass through facility”.
- Prepared new datasets from raw data files using import techniques and modified existing datasets using Set, Merge, and Sort, Update and other procedures and functions.
- Created clinical data tables like demography summary tables, Adverse Effects (AE), Serious Adverse Effects (SAE), Quality of Life (QOL) tables.
- Developed, validated and documented programs to create TLG’s (Tables, Listings and Graphs) as per Statistical Analysis Plan (SAP) using SAS reporting procedures like PROC REPORT, PROC TABULATE, graphic procedures like PROC GPLOT, PROC LIFETEST and analysis procedures like PROC MEANS, PROC UNIVARIATE and PROC FREQ.
- Developed and used SAS Macros programs to generate reports, tables and listings for clinical and bio-statistical review.
- Performed CRF-Annotation with respect to SAS variable names to aid programming.
- Generated Ad-Hoc reports for further analysis using SAS tools.
- Created SAS reports using the Data _Null_ technique and PROC REPORT for NDA submission as per FDA regulations and company standards.
- Used PROC COMPARE to conduct quality control checks on files, tables and listing.
- Created transport files for FDA submissions.
- Developed HTML, RTF and PDF reports using SAS ODS.
Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/ACCESS, SAS/STAT, SAS/CONNECT, Excel, Access, Oracle Clinical, SQL, PL/SQL, UNIX and Windows XP.
Confidential, Northbrook, Illinois April 2008 – March 2010
Role: Sr. SAS Application Developer
Project: Hercules, I Benefits, Program Data
- Worked extensively with business users on requirements gathering, analysis and documentation.
- Used SAS (Base SAS, Data Step, and PROC SQL) and SAS macro language with processing files of at least 5 million records of healthcare claims data.
- Extracted claims data from various databases like Oracle, DB2, SQL server, etc. using SQL Pass through Facility.
- Provided insight to the sales/retail organization as to appropriate sales strategies and tactics using information and research findings.
- Identified growth opportunities to increase reach and circulation.
- Provided demographic analysis of telemarketing campaigns using Unix SAS for call list target market and call center effectiveness determinations.
- Worked on data cleaning, merging data from multiple files (e.g. medical, pharmacy), applying project-specific inclusion/exclusion criteria, coding project-specific variables and producing participant/member-level datasets.
- Designed and tested prescription, over the counter and retail evaluation programs/mailings.
Environment: BASE SAS, SAS/MACROS, SAS SQL, SAS/STAT, SAS/GRAPH, SAS ODS, SAS/ACCESS, SAS/CONNECT, SAS EG, Windows and UNIX.
Confidential, NJ August 2007 – March 2008
Role: SAS Programmer (Clinical)
Nostrum Pharmaceutical is a biopharmaceutical company dedicated to discovery and development of biologically active compounds derived from natural sources. The objective of this project is to process clinical trial for phase I and II and to generate clinical trial reports for FDA submission.
- Coordinate with clinical data management team and generated safety and efficacy tables (demography, pharmacokinetics, vital signs, and lab).
- Based on the SAP, manipulated different variables in the datasets.
- Used different statistical procedures to bring up an inference on different occasions.
- Develop MACROS for various routines depending upon the necessity.
- Support for monitor and quality assurance of data from clinical trials.
- Computed ad-hoc reports for various statisticians’ requirements.
- Studied the protocol and CRF validate the data and check for data entry errors.
- Involved in the development of flow charts for the SAS programs with the details of SAS datasets used and how they were used and worked accordingly.
- Developed close working relationships with other members of the Statistics team.
- Review the protocol, case report forms (CRFs), statistical analysis plan (SAP) for Clinical trials.
Environment: SAS 8.2, SAS/MACROS, SAS/SQL, SAS/Graph, Oracle 9, PL/SQL, SAS/STAT, Oracle Clinical, MS Office, UNIX and Windows NT.
Confidential, India August 2006 – June 2007
Role: SAS Programmer
Vimta Labs is one of the emerging global pharmaceutical companies. It provides expert services in all the key areas of drug development processes like Clinical Trial Management (CTM), Medical Writing, Pharmacovigilance and Product Safety Services. As a part of the clinical trials, the project involved randomized trials on Dermatologic conditions of patients. Our team was responsible for developing various SAS procedures, applications, programs for the data. I worked as SAS programmer in the clinical trial data in the generation of various reports.
- Analyzed three phases (I-III) of the Clinical Trials in different therapeutics areas.
- Developed SAS programs using SAS/BASE, SAS/SQL, SAS/MACROS, SAS/STAT and SAS/GRAPH and for statistical analysis and data displays.
- Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE.
- Contributed to ongoing preparation of SAS datasets for statistical analyses and demonstrations.
- Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
- In-depth knowledge of programming and reporting with Base SAS, SAS/STAT, SAS Language, SAS/ODS and Graph.
- Macros were written at various instances for automating listings and graphing of clinical data for analysis.
- Participated in edit check program development, testing and implementation when required by in house data management system.
- Generate reports either in HTML, PDF or RTF formats according to the client specifications.
Environment: SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, Oracle, Windows.
Confidential, India October 2005 – July 2006
Role: SAS Trainee/Programmer
Panacea Biotech is a progressive research based Health Management Company. The company is involved in research, manufacturing and marketing. The company also serves internationally for the pharmaceutical and biotech industries with offices in the US, Europe.
- Experience in utilizing SAS Procedures and other SAS applications for data updates, data cleansing and reporting.
- Identify and correct data step syntax and programming logic errors.
- Efficient in using data step programming to solve complex programs.
- Experienced inImportandExportof clinical data across a variety of applications to and from SAS.
- Experienced in validation 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.
- Proficient inSAS/BASE, SAS/ODS, SAS/SQLand experience in producing external files and reports employing various SAS procedures likePROCPRINT, PROC REPORT, PROC SUMMARY.
- UsedSASdata step functions, formats, statements and procedures like PROC FORMAT and to map the variables to the customer’s needs. Involved in writing code using BASESASandSAS/Macros to extract clean and validate data from oracle tables.
Environment:SASV8, SAS/BASE, SAS/SQL, SAS/ODS, Windows 98, Excel/Access 2000.
- Bachelor of Biotechnology