SUMMARY:

• Over 5 years of experience in SAS programming with good knowledge of advanced statistical methodologies applied in Pharmaceutical and Biotech industries.
• Expertise in analyzing and reporting various phases (Phase I - IV) Of Clinical Trials using tools like Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/MACRO, SAS/ACCESS and SAS/ODSin UNIX and Windows environment.
• Working knowledge of General linear models, Categorical data analysis, Survival analysis, Multivariate analysis, Design of experiments, longitudinal data analysis, randomized trial designs and survey design and analysis.
• Experience in providing statistical support for clinical studies, including design of studies, selection of appropriate statistical methodologies and tests, sample size and power calculations, randomization, statistical analyses, and interpretation of results.
• Experience in debugging and testing SAS programs to check and process data, generate graphs, tables and listings in analysis system.
• Individually capable of developing new SAS Programs and/or enhancing existing SAS programs from protocols and SAP’s.
• Experience in Data manipulation and producing reports employing various SAS procedures like PROC SQL, PROC REPORT, PROC TABULATE, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC SUMMARY, and PROC CONTENTS.
• Hands on experience in SAS programming for importing and exporting huge data sets from Flat files, Excel spreadsheets and external RDBMS (ORACLE) tables using LIBNAME and SQL PASSTHRU facility.
• Hands on experience in Oracle, PL/SQL programming to create Triggers, database Packages Procedures/Functions. Creation of database objects like Tables, Views, and Synonyms etc.
• Extensive use of SAS/ACCESS, SAS/CONNECT to connect to various databases such as development and production database (DB2 on UNIX).
• Experience in reviewing case report forms CRF’s/SDTM/ADaM to ensure that the protocol objectives are met and the project standards are maintained.
• Working knowledge of medical terminology in clinical trials, clinical trial methodologies, and software systems development.
• Exposure to CDISC Standards, 21 CFR Part 11, GxP guidelines, Bioethics, IRB guidelines, HIPAA guidelines and Regulatory Submissions (CSR, BLA, NDA, including ISE and ISS).
• Efficient in maintaining working relationships with clients and internal project members, including data managers, research scientists, and other statistical programmers.
• Experience in developing and maintaining statistical documentation, including description of statistical methods, SAS programs, results and discussion.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Possess a strong ability to adapt and learn new technologies and new business lines rapidly.
• Effective team player with strong communication & interpersonal skills.

TECHNICAL SKILLS:

SAS skills: Base SAS, SAS/Macro, SAS/Connect, SAS/SQL, SAS/STAT, SAS/BI,SAS/ETL, SAS/Graph, SAS/IntrNet, SAS/ODS, SAS/Access, SAS Enterprise Guide, Enterprise Miner, SAS Stored Processes Web Application, SAS Web Report Studio, SAS Information Map Studio, SAS Forecast studio, SAS Visual Analytics, SAS DI Studio and Management Console.

SAS Procedures: Print, Transpose, Contents, Means, Chart, Plot, Tabulate, Summary, Sort, SQL, Freq and Formats

Databases: MS Access, SQL Server, MySQL, Teradata, and Oracle

Operating Systems: Windows, Unix, Linux and Mac

Software packages: MS Word, MS Excel, MS PowerPoint, and SQL Plus

Reporting Tools: Base SAS versions 9.4/9.3/9.2/9, SAS Enterprise, SAS Graph, MS-Excel, SAS BI Platform, and MS PowerPoint.

PROFESSIONAL EXPERIENCE:

Confidential, Roanoke, VA

Sr. Clinical SAS programmer / Statistician

Responsibilities:

• Responsible for providing Clinical SAS programming and analysis support for clinical studies across multiple protocols for the submissions like CSR and Safety.
• Responsible for Developing reports for Safety and efficacy as per study requirements.
• Involved in Developing, Debugging, and validating the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings according to departmental standards.
• Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.
• Performed QC (Quality Check) extensively on tasks performed by other team members and involved in data validation and data cleaning in all phases of Clinical studies.
• Extensively used Proc SQL to retrieve, update and report on information from SAS data sets and other database products.
• Modification of existing SAS programs and creation of new programs using SAS Macros.
• Built Macros and create macro variables using %LET, CALL SYMPUT, and DATA NULL to help generate analysis data sets and create specified structure of TLFs.
• Ability to quickly debug SAS compiling errors, to review SAS code and quickly identify areas of concern.
• Worked with Statisticians and Clinical Data Managers to provide SAS programming in analyzing the Clinical Trials and generating Reports.
• Created analysis datasets based on the guidelines provided in the Data Definition Tables (DDT) and following the CDISC standard. Used SDTM model (3.1.1)/ ADAM for domain creation and CDISC compliant analysis datasets.
• Used Proc CDISC for verifying compliance of datasets with CDISC standards and electronic submissions.
• Worked on multiple protocols and/or drug compounds at a time.

Environment: SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, and ORACLE.

Confidential, Oakland, CA

Sr. Clinical SAS programmer

Responsibilities:

• Provided SAS Programming and analysis support for phase III (oncology) clinical trials.
• Co-worked with Statisticians as a primary SAS programmer to analyze initial data sets and create tables, listings and figures (TLFs) for clinical trials.
• Created tables, graph to generate clinical study reports for the collected requirement from the statisticians referring to the Statistical Analysis Plan (SAP).
• Extracted data from ORACLE database and involved in cleaning the data (data cleansing) using various edit check techniques.
• Used procedures like PROC TRANSPOSE, PROC SORT, etc in Data transformation and Manipulation processes.
• Extensively used Proc SQL, Proc Transpose, Proc Format, Proc Means, Proc Univariate, Proc Freq, Proc Printto and Proc Compare for checking the assumptions and conducting Statistical Analysis.
• Effectively developed SAS code for modeling data and implemented SAS/STAT procedures such as Proc Lifetest, Proc lifereg, Proc Phreg, proc reg and Proc Glm for Survival analysis, logistic regression analysis and other statistical analyses.
• Produced Ad hoc reports of various kinds like Listings, Tables, and Figures (TLGs/TLFs) using Proc Report, Proc Tabulate, Data Null technique, Proc Gplot etc.
• Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML
• Validated analysis data sets and SAS outputs with other programmers’ outputs and mockups in SAP using PROC COMPARE, PROC CONTENTS, and PROC FREQ. Created formats for the coded data and used PROC SQL for data validation.
• SAS macros were successfully used to create new programs and modified existing SAS programs to make them portable as well as for consistency of results.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Majorly worked with the data management team and was involved in handling documentation and submission processes (under managers’ assistance).

Environment: SAS/BASE, SAS/ACCESS, SAS/MACROS, SAS/STAT, and ORACLE

Confidential

Statistical programmer

Responsibilities:

• Provided SAS programming support to Bio-statisticians and data management team for analyzing clinical trial data and validation of tables, listings and reports.
• Extracted Clinical trial data from Oracle database by using Proc SQL Pass through Facility.
• Data Cleansing to remove erroneous data entered by using edit check programs before the data analysis.
• Responsible to write, modify, validate and implement SAS programs according to Statistical Analysis Plan (SAP).
• Produce safety summary results with tables, listings, and graphs, performing quality control of other programmers work and debug complex programming code.
• Extensively used procedures like PROC SUMMARY, PROC UNIVARIATE, PROC MEANS, PROC TABULATE, PROC GPLOT, PROC FREQ, PROC COMPARE, PROC REPORT and PROC TRANSPOSE and other statistical procedures like PROC ANOVA, PROC GLM AND PROC REG.
• Generated reports using Data steps and various procedures such as Proc Sort, Proc MEANS Proc Tabulate, Proc Freq, Proc SQL, Proc Reports and Macros.
• Used SAS tools like Proc SQL to perform queries, join tables, create and manage tables.
• Validation of datasets and TLGs and peer reviewing of the fellow programmers’ code.
• Developed and validated standard and custom data listing, datasets, summary tables, and Graphs as per requirement and standard protocols and involved in study designs.
• Contributed to Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) and Reports for clinical Studies.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• CDISC mapping using SDTM model- created data tabulations and verified using Proc CDISC. Worked with different classes (intervention, events, findings, special purpose).

Environment: BASE/SAS, SAS/MACRO, SAS/STAT, SAS/GRAPH and ORACLE

Confidential

Statistical programmer

Responsibilities:

• Generated statistical analysis files, tables, listings, and graphs for Phase III drug trial studies.
• Collaborated with Statisticians, Data Manager, and other SAS programmers to provide ad-hoc and routine analyses and reports with regards to the assigned projects.
• Support Data management in data creation/transfers and integrity checks
• Imported external files like Excel files, text files, and Database files into SAS data sets using INFILE, LIBNAME, PROC IMPORT, SAS/Macros, and SAS/Connect, etc.
• Used various procedures such as Proc Means, Proc Freq and Proc Univariate to check assumptions and produce initial analyses.
• Worked with different clinical trials data like Demographic, Medical History, Vital signs, Adverse Event (AE), Physical examination.
• Created SAS data sets by extracting data from various sources and prepared them for statistical analysis. Manipulated data sets by using RETAIN, ARRAY, DATA NULL, SAS Functions, etc.
• Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.
• Created Summary Reports and Tabular Reports using Proc Report and Proc Tabulate.
• Written custom safety and efficacy reports by directing SAS output to RTF and HTML files using SAS/ODS.
• Ensured analysis data and programming code meet regulatory and company standards (FDA and ICH regulations) and are consistently structured to permit efficient programming and reporting.
• Cross-validated programs with others: compared outputs and proofread the coding.

Environment: BASE/SAS, SAS/ACCESS, SAS/MACRO, SAS/CONNECT, SAS/STAT and ORACLE

Confidential

Jr. Statistical programmer

Responsibilities:

• Data manipulation on SAS data sets using techniques such as merging, appending, concatenating and sorting.
• Imported huge data in to SAS library and sorted according to the class of the drug using ORDER BY option.
• Responsible for initial exploratory analyses, checking assumptions for required tests.
• Produced outputs in different formats such as HTML and PDF and using SAS/ODS.

Environment: SAS/BASE, SAS/STAT, WINDOWS and MS EXCEL