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).

PROFESSIONAL EXPERIENCE

Confidential, TROY, MI

SAS - STATISTICAL 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 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.
• 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, SAN JOSE, CA

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, NY

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

RESPONSIBILITIES:

• Created Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study for statistical analysis
• 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.
• 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.