Professional Summary:

• Having 7 years of experience in performing analytic SAS/statistical programming for clinical trials for client companies using SAS on Windows and UNIX platforms.
• Statistical programming related to the design, programming, implementation, maintenance, and validation of Clinical trial information for the submission to the FDA during various phases.
• Experience with transforming data in various formats excel, csv, delimited files, ASCII to and from SAS Datasets using Proc Import and Export.
• Developed study specific Edit Checks and Validation to clean the database using SAS Procedures, Macros, and Reports for Clinical Data management.
• Generated Ad-Hoc Reports for post Marketing Pharma covigilence analysis datasets and delivered Data Dumps for Clinical Data management before /after database lock.
• Created derived Datasets from raw data sets based on SAP developed by bio-statistician.
• In-depth knowledge of statistical analysis techniques for clinical studies, and excellent experience in analyzing safety efficacy data for Phases I-III of clinical trials.
• Utilizing advanced SAS skills, including Macros and SQL procedures to deliver concise and flexible code.
• Making efficient usage of SAS functions and procedures, including common statistical procedures.
• Familiar with standard dictionaries such as MedDRA and WHO Drug.
• Generated HTML, Excel, RTF and PDF reports using SAS ODS.
• Extensive experience in Clinical Data Management, data analysis, and to generate CRT tables, reports, graphs for FDA submission according to protocol.
• Quick learner and excellent team player consistently meet deadlines and can work under pressure.
• Highly organized and dedicated with a positive attitude and self motivated. Good written, oral, and interpersonal communication skills.
• Accustomed to working in challenging environments under deadlines, excellent analytical, and problem solving skills.

Technical Skills:

PROFESSIONAL EXPERIENCE:

Confidential

SAS Programmer

Responsibilities:

• Performed CDISC SDTM Mapping of variables to make the raw data conform to the SDTM model.
• Build the domain models according to SDTM specs and also created new domains according to CDISC compliant
• Contributed in analysis of PK/PD by creating ADaMs with parameters such as Cmax, Tmax and AUC.
• Developed Listings, Tables and Graphs to access Safety and Efficacy during Phase I-III trials Randomized, Blinded, Well controlled studies and Open label studies.
• Created Analysis Data Set from raw data sets according to specifications by self creation based on mock shells and SAP.
• Involved in the development of clinical trial data tables Demographic data tables, Adverse Events AE tables, Serious Adverse Events SAE tables, Laboratory data tables etc.
• Generated Reports and Listings using Proc Report, Proc Means, Proc Freq, Proc Univariate, Proc Print, Proc Transpose, Macro statements, Macro functions, and Standard Macros.
• Conducted statistical modeling for both continuous and categorical data, including linear regression, nonlinear regression, ANOVA, GLM model, repeated measure, non-parametric regression etc.
• Given presentations on SAS/STAT procedures like Extension of PROC TTEST options in SAS/STAT 9.2., Categorical analysis using PROC FREQ etc.

Confidential

SAS Programmer

• Worked on Double Blinded, Placebo Controlled and Parallel Study trials.
• Performed analysis on the Clinical data of Phase II and Phase III for multiple studies.
• Worked as Primary programmer for one project and QC programmer for the others.
• Developed programs for the Data Quality Review Plan DQRP .
• Developed Listings, Tables and Graphs to access Safety and Efficacy tables that are required for the Clinical Trial Report CTR.
• Performed validation activities to ensure the quality of the electronic submission.
• Created CRT Datasets used for FDA Submissions using CDISC Standards.
• Performed SAS Edit Checks on the raw SAS data sets.
• Worked closely with statistician to create Analysis datasets with primary and secondary endpoints and also generated the efficacy tables based on primary and secondary endpoints
• Developed routine, user friendly SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions.
• Worked on QC of analysis datasets, Tables and Listings.
• Convert Flat files and MS-Excel tables into SAS Datasets.

Confidential

SAS Programmer

Responsibilities:

• Data migration from Excel, CSV, Tab, DLM, DAT and flat files into SAS data sets and Created CRFs for the clinical study.
• Performed Study Specific Edit Checks and General Edit Checks.
• Created derived Data Set from raw data sets based on SAP.
• Worked with Statisticians to analyze the clinical data, tables, listing, and generated reports and graphs.
• Generated Efficacy and Safety tables Demographic listing, Adverse Events, Vital Signs, Lab Descriptive .
• Used appropriate statistical procedures and generated statistical output.
• Generated Reports and Listings using Proc Report, Proc Means, Proc Freq, Proc Univariate, Proc Print, Proc Transpose, Macro statements, Macro functions, and Standard Macros.
• Provided descriptive statistics using Proc Means, Frequency, and Univariate.
• Created Macros for repetitive tasks for generating AE reports, Abnormal Labs/Vitals signs/ECGs.
• Worked with statistician for Survival Analysis, used proc Lifetest, Phreg, and Logistic Used Proc GPlot and GChart for plotting plasma concentration and mean plasma concentration.
• Created Transport file and Data Definition Document DDD reports for E-submission.
• Performed gap analysis and CDISC SDTM mapping.

Confidential

SAS Programmer

Responsibilities:

• Developed programs for Phase II and III clinical trials to create SAS datasets.
• Plan and coordinate programming, testing, and documentation of statistical programs for use in creating statistical tables, graphics, and listing summaries.
• Reviewed and provided feedback on case report form designs, CRF annotations, edit checks and SAP.
• Created Analysis Data Set from raw data sets according to specifications by self creation based on mock shells and SAP.
• Generated reports and listings using Proc Report, Proc Means, Proc Freq, Proc Print, Proc Transpose, Macro statements, Macro functions and Standard Macros.
• Incorporated MedDRA terms in the existing Adverse Event data by creating a mapping Macro.
• Used SAS ODS for generating reports in specific output formats like RTF, PDF, and HTML.
• Created CRT's Case Report Tabulations using CDISC standards for submissions to the FDA.
• Successfully validated TLG's through independent validation using Proc compare and departmental macros.
• Extracted data from different sources and converted the data into SAS data sets using Proc Sort, Merge, Proc SQL procedures.
• Developed macros to map the datasets using CDISC standards.
• Used SAS Macros in creation of new programs as well as modification of existing programs.
• Performed Data Cleaning, Data Validation according to the requirement of Clinical and Data Management Department DMD .

Confidential

SAS Programmer

Responsibilities:

• Created reports in different formats like RTF, PDF and HTML using SAS output delivery system ODS .
• Created analyzed Datasets from raw data files and modified existing datasets using Set, Merge, Sort, and Formats, Functions and conditional statements.
• Used PROC SQL, FREQ and MEANS for data analysis and generating report using TABULATE and REPORT.
• Worked with different clinical trials data like Demographics, Adverse Event AE , Serious Adverse Event SAE , Laboratory and Physical Examination.
• Performed Data Validation and Data Cleaning on Clinical data using procedures like Proc Freq, Proc compare and departmental macros.
• Modified existing data sets by using the statements like SET, MERG, UPDATE and Conditional statements.
• Implemented statistical modeling for both continuous and categorical data, including ANOVA, GLM model, etc.
• Analyzed descriptive statistics using various Proc Means, Proc Freq, Proc Summary, Proc SQL and Proc Univariate.

Confidential

Consultant Mainframe

Responsibilities:

• Analyzing Technical specification document.
• Analyzing the PL/I and Cobol code in mainframe.
• Extracting the Business Logic.
• Preparing Business logic document for the programs analyzed.
• Sending daily status reports and issue logs to Onsite team.
• Worked as a peer-reviewer by performing Data Validation and Data cleaning.

Environment: IBM OS/390, COBOL II, SAS, JCL, TSO/ISPF, MVS, File-Aid