SUMMARY

• Six plus years of experience in SAS® programming on various projects in Pharmaceutical industry/Biotechnology/CRO.
• Strong understanding of requirements in new drug development and Clinical trial phases (I - III) from protocol through FDA submissions. This includes preparation of NDA, safety and adverse event report reviews.
• Worked on various Clinical trial designs including open-labeled, single blinded, double blinded, randomized, parallel and crossover studies.
• Worked on various therapeutic areas like General Medicine, Pain, Metabolic, Dermatology, Infectious Diseases, Neurology.
• Good knowledge of coding adverse events and concomitant medications datasets with MedDRA and WHO Drug dictionaries.
• Created SDTM (version 3.1.1, 3.1.2) datasets for several domains such as AE, CM, LB, VS, DM, SE, EG, EX, IE etc. and their SUPPQUAL datasets from raw datasets by following CRF, Dataset Specifications and CDISC SDTM Implementation Guide.
• Experience in creating SAS datasets, producing analysis datasets (ADaM) (IG 1.0, 2.0), SAS procedures, generating TLFs/reports, supporting ISSs/ISEs for NDA -FDA Submission.
• Experience in developing macros, preparing data specifications documentation, validating other programmer’s output adhering to CDISC SDTM standards.
• Proficient in understanding of Study protocols, SAP (Statistical Analysis Plan), CRF and Raw Data.
• Worked closely with data manager, biostatistician and other senior programmers in handling several projects. Managed and produced deliverables in a timely manner and within budget.

TECHNICAL SKILLS

Operating Systems: Windows XP / 7 / 8

Statistical Software: SAS V9.2, V9.1.3, Base SAS, SAS/MACRO, SAS/Connect, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/Access, SAS/Assist, SAS Enterprise Guide, SPSS, GIS, Access.

RDBMS: MS Access, Oracle

SAS Procedures: Sort, Transpose, Tabulate, Report, Print, Contents, Means, Freq, Chart, Plot, Univariate, Summary, Anova, Corr, Glm, Mixed, Reg, SQL, Copy, Import, Export, Datasets, Format, Boxplot, Append.

Tools: MS Access, Excel, Word, PowerPoint.

Web technologies: HTML, XML

PROFESSIONAL EXPERIENCE

Confidential, IL

Clinical SAS Programmer

Responsibilities:

• Assisted and developed SAS programming and analysis support for Phase III clinical study.
• Used Dynamic Data Exchange (DDE) for importing and exporting of data from and into SAS, MS Access and Excel.
• Performed Data Cleaning and Validation using SAS data step and SAS procedures.
• Produced summaries and statistics using PROC MEANS, PROC SUMMARY, PROC FREQ, PROC ANNOVA and PROC UNIVARIATE.
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets and/or ASCII files by using Set and Merge for generating Reports and Graphs.
• Generated tables, reports, listings and graphs including Patient Demography and Characteristics, Adverse Events, Laboratory etc. according to Statistical Analysis Plan (SAP) using PROC REPORT, PROC GPLOT for Clinical Study Reports in compliance with 21 Code of Federal Regulations (21 CFR Part 11), ICH-GCP guidelines.
• Worked closely with Manager, Statistician in analyzing datasets and studying populations in electronic databases.
• Assisted in the development of Statistical Analysis Plans, reviewing study protocols and reports.
• Provided outputs for the Clinical Study Report (CSR).
• Analyzed Adverse Event (AE) data using PROC FREQ.
• 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.
• Extensively used Data Null and SAS procedures such as Print, Report, Tabulate, Freq, Means, Summary and Transpose for producing ad-hoc and customized reports and external files.
• Created CRTs with datasets in Transport File Formats and Data Definition Tables for NDA submissions to FDA.
• Worked with CDISC data models including SDTM, ADAM.
• Develop new or modify SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
• Cross-Validated SAS programs authored by other SAS programmers as a part of QA (Quality Assurance) analysis.
• Used SAS ODS to create HTML, RTF and PDF outputs files in the process of producing reports.

Environment: SAS/Base 9.2, SAS/Macros, SAS/STAT, SAS/Graph, SAS/ACCESS, SAS/ODS, SAS/CONNECT, SAS/SQL, Windows, MS-Excel, MS-PowerPoint.

Confidential, CA

SAS Programmer

Responsibilities:

• Developed SAS program to load data from the source and created study specific datasets, which are used as source datasets for report generating programs.
• Exposure to various procedures like Proc Print, Proc Report, Proc Means, Proc Freq, Proc Compare, Proc Transpose, Proc Tabulate, Proc Summary, Proc Sort, Proc Sql, Proc Univariate, Proc Export, Proc Import, Proc Format, Proc Contents and Proc Plot.
• Performed statistical analysis on clinical studies including randomization, sample size calculations, power analysis, parameter estimation and hypothesis testing. SAS /STAT procedures such as UNIVARIATE, TTEST, ANOVA, FREQ and MEANS were used to carry these analyses.
• Analyzed, interpreted and translated complex measurements from clinical trial into concise and accurate summaries.
• To improve ease and consistency of results, developed SAS Macros and documented their algorithm.
• Involved in creating define.pdf, converting SAS datasets to transport files as a part of E-Submissions.
• Generated Tables, Graphs and Listings for inclusion in clinical study reports and regulatory submissions according to SAP and Protocol.
• Involved in data cleaning and creation of SDTM datasets from raw data as per CDISC Standards.
• Generated ad-hoc listings using Proc Print, Proc Report, Data Null and Proc Sql.
• Generated output files in text format, HTML, RTF & PDF format usingSAS ODS.
• Worked with Bio-Statisticians, Data Managers and Clinical Research managers as required.

Environment: SAS/BASE, SAS/SQL, SAS/STAT, SAS/MACROS, SAS/ODS, SAS/GRAPH, MS-Excel, Windows.

Confidential, CA

Clinical SAS Programmer

Responsibilities:

• Worked extensively to generate SAS data sets, statistical reports, monthly reports, listings, and safety reports for cross-functional teams for Phase I - II ofclinicalTrial Data.
• Created edit check programs to find data discrepancies in raw datasets provided by Data Management Group.
• Generated tables, listings and graphs according to Protocol and Statistical Analysis Plan (SAP) using PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC GCHART and PROC GPLOT Procedures.
• Created SAS Customized Reports using the Data Null technique. SAS/STAT procedures such as UNIVARIATE, FREQ, and MEANS were used to carry out analyses and theSASREPORT procedure is generally used to display results.
• Assisted statisticians and company CDISC standard team in determining type of SDTM domains for therapeutic specific datasets.
• UsedSASODS to produce HTML, PDF and RTF format files.
• Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Graphs.

Environment: SAS (BASE, SQL, ODS, MACROS, IT, ETS), Windows, MS-Excel and Access