SUMMARY:

• 6 years of experience in Pharmaceutical industry involving data management and statistical analysis for clinical trials.
• Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/ACCESS, SAS PC V9.0 , SAS/GRAPH.
• Worked with Statisticians in analyzing the Clinical Trial Data, generated reports, tables, listings and graphs using SAS in accordance with the Statistical Analysis Plan SAP , Standard Operating Procedures SOPs and departmental guidelines.
• Experience in extracting data and creating SAS datasets from various sources like Oracle database, Access database, Excel and flat files using Import techniques.
• Experience in developing Macros using SAS procedures.
• Experience in developing programs required for ISS ISE analysis reports.
• Experience in developing, validating and implementing SAS programs and produce derived datasets for analysis and generating documenting tables, listings and graphs for clinical study reports.
• Excellent knowledge of SAS Procedures: PROC FREQ, PROC UNIVARIATE, PROC REG, PROCTTEST, PROC ANOVA and PROC NPAR1WAY Categorical and Continuous data analysis .
• Generated reports using PROC REPORT, DATA NULL and PROC TABULATE for customized report writing.
• Experience in producing RTF, PDF, and HTML files using SAS ODS.
• Good understanding of Clinical Trial Phases, clinical protocols/ CRF's/Annotated CRF's, ICH and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11. Familiar with Electronic submission guidelines to FDA.
• Strong communication skills and can work well in a team.

TECHNICAL SKILLS

• SAS Tools: SAS V9, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/REPORT, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/CONNECT.
• Languages: SAS, SQL, HTML
• Database: MS Access, MS Excel, MS SQL, Oracle Clinical
• Others: MS OFFICE Word, PowerPoint, Excel, Visio .

WORK EXPERIENCE

Confidential

SAS-STATISTICAL PROGRAMMER

RESPONSIBILITIES:

• Created new analysis datasets from raw datasets for clinical trials.
• Created Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study for statistical analysis.
• Data validation and quality control check of the displays and datasets according to the different QC levels.
• Supported preparation of Electronic Common Technical Document e-CTD and Case Report Tabulation CRT .
• Generated CRT Case Report Tabulation datasets using CDISC standards for FDA regulatory submissions.
• Worked on the summary of clinical data like Demographic, Adverse Events AE , Serious Adverse Events SAE , Adverse Events by System Organ Class and Preferred Term, Related Adverse Events and Adverse Events Leading to Discontinuation.
• Extensively worked on PROC REPORT to produce reports for the purpose of validation.
• Evaluated and provided input on SAP for individual and pooled clinical data sets.
• Review and acquired knowledge about documents related clinical trials like clinical protocol, SAP, Clinical Study Report and aCRF Annotated CRF .
• Involved in problem solving, data analysis, and complex report generations.
• Extensively involved in creating safety and efficacy tables, listing and figures.
• Performed Quality Checks on the existing table, listing and figures.
• Extensively used company standard macros for effective and efficient outputs for clinical trials. Created study specific macros for better performance.
• Extracted data from Oracle Clinical and validated the data to check its consistency by using SAS procedures like UNIVARIATE, FREQ and also checked the values with annotated CRF.
• Developed various forms of output such as RTF, PDF, and HTML files using SAS ODS facility.
• Participated in Weekly Meeting with Team Lead, Co-workers to discuss about the work progress and queries regarding the project.

Confidential

SAS PROGRAMMER CONSULTANT

RESPONSIBILITIES:

• Created Data specs / DDT Data definition Tables .
• Developed specifications for database in CDISC format and involved in programming datasets in CDISC format STDM model 3.1 and managed CDISC database for several studies.
• Produced analysis datasets, tables, listings and graphs.
• Validated analysis datasets, tables, listings and patient profiles
• Developed SAS programs to generate randomization lists, statistical reports and graphs.
• Used Dynamic Data Exchange DDE feature of SAS for importing and exporting of data from and into SAS and Excel.
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets.
• Created complex and reusable Macros and extensively used existing macros.
• Developed SAS programs for data cleaning, validation
• Customized existing macros to generate specified tables.
• Developed SAS programs for creating intermediate data sets, generating statistical reports and graphs as per statistical analysis plan.
• Graphical and html reports were generated on demographics, safety and baseline characteristics
• Reviewed reports for consistency between text and summaries.
• Provided SAS programming support on conducting analysis of Safety efficacy studies for clinical trial data
• Investigated missing data and data anomalies in SAS data sets.

Confidential

SAS PROGRAMMER CONSULTANT

RESPONSIBILITIES:

• Successfully designed and implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I, II and III Clinical Trials.
• Used Dynamic Data Exchange DDE feature of SAS for importing and exporting of data from and into SAS and Excel.
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets.
• Created complex and reusable Macros and extensively used existing macros.
• Developed SAS programs for data cleaning, validation.
• Generated ad-hoc reports for raw datasets using Print and Report procedures.
• Delivered data dumps for Clinical Data Management before database lock.
• Developed safety listings, tables and plasma concentration graphs for clinical study team and bio-statistical team review.
• Attended project team meetings, worked with Bio-Statisticians, Data Managers, and Clinical Research Managers as appropriate. Reviewed and provided feedback for Data Integrity Plans.

Confidential

SAS PROGRAMMER

RESPONSIBILITIES:

• Extracted data from Oracle Clinical and validated the data to check its consistency by using SAS procedures like UNIVARIATE, FREQ and also checked the values with annotated CRF.
• Created Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study for statistical analysis.
• Modified Tables and Datasets in Phase II-III study according to the requirements of the statisticians.
• Data validation and quality control check of the displays and datasets according to the different QC levels.
• Supported preparation of Electronic Common Technical Document e-CTD and Case Report Tabulation CRT .
• Generated CRT Case Report Tabulation datasets using CDISC standards for FDA regulatory submissions.
• Worked on the summary of clinical data like Demographic, Adverse Events AE , Serious Adverse Events SAE , Adverse Events by System Organ Class and Preferred Term, Related Adverse Events and Adverse Events Leading to Discontinuation.
• Extensively worked on PROC REPORT to produce reports for the purpose of validation.
• Evaluated and provided input on SAP for individual and pooled clinical data sets.
• Involved in problem solving, data analysis, and complex report generations.
• Used statistical procedures like PROC MEANS, PROC UNIVARIATE, and PROC FREQ for analysis.
• Developed various forms of output such as RTF, PDF, and HTML files using SAS ODS facility.