Professional summary

• Over 7 years of experience as Clinical SAS Programmer and SDTM Analyst in clinical domain
• Worked on various therapeutic areas such as Gastroenterology, Neurology, Cardiovascular and Metabolic disorders Clinical Trials.
• Implementing CDISC standards to clinical trial data through converting raw datasets to SDTM datasets with reference of mapping documents prepared by following SDTMIG.
• Preparing analysis datasets from SDTM datasets. Have experience in analyzing clinical data, creating tables, listing and generating reports.
• Fluent with the applied aspects pertaining to SAS Programming using SAS/Base, SAS/Access, Macro, SQL, SAS/Connect, SAS/Enterprise Guide, SAS/Stat SAS/Graph
• Assisted in generating Annotated Case Report Form CRF design and development.
• Experience in all aspects of Clinical trials: experimental design, selection of appropriate statistical methodology, data analysis and summarization, reporting and submission of applications.
• Good experience New Drug Device Release process and IND submission to getting approved from FDA.
• Strong Knowledge of ICH-GCP guidelines and 21 CFR Part 11
• Experience in Base SAS, SAS/Macros, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/ODS, SAS/SHARE, SAS/CONNECT, SAS Enterprise Guide and SAS SQL.
• Strong expertise in SAS Base procedures, Reporting and Summary procedures and experience with PROC SQL, SAS DDE and SAS Arrays.
• Using ODS to generate HTML, PDF, RTF and LISTING output.
• Experience in CDISC, Study Data Tabulation Model SDTM , and ADaM.
• Experience in Data Management tasks such as data extraction, data validation, data manipulation, data processing, data transformation, data cleaning and data loading.
• Proven experience with Windows and UNIX operating environments.
• Highly determined and motivated with willingness to accept responsibility.

Technical Skills

Professional Experience

confidential

Clinical SAS Programmer

Protocol Title: A Phase 1 Placebo-Controlled, Randomized, Double-Blind, Dose Escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled Study drug in Healthy Adults and Adults with Mild Asthma

Responsibilities:

• Deriving analysis datasets from SDTM datasets as per Analysis dataset spec ADaM .
• Generating the SDTM datasets from raw datasets as per CDISC SDTM 3.1.2.
• Understanding the study related documents such as Protocol and SAP.
• Generating Tables and Listings as per the SAP specifications.
• Validating Tables, Listing and derived datasets using proc compare procedure.
• Updating communication log and program work sheets
• Coordinating with the Team lead and with the bio statistician.
• Generating SAP required reports by using proc report and data null .
• Used ODS in the generation of outputs in required formats like RTF, PDF and HTML etc.
• Created HTML and RTF reports using SAS Output Delivery System ODS .
• Contributed to Case Study Reports CSR and documents to be submitted to FDA.

Environment: BASE SAS v9.1, SAS/MACROS, SAS/GRAPHS, SAS/ODS, SAS/STAT, Oracle Clinical, WINDOWS XP.

confidential

Clinical SAS Programmer/Data Analyst

• Project description: It is an open label prospective, non-comparative and multi-center study. A total of 100 patients will be enrolled in study. The study scheduled to have 8 visits with one week of screening visit , 4 week of run in period visit 2 and 24 weeks of treatment period visit 3 to visit 8 to assess safety and efficacy. Drug has proved to be safe and effective in reducing disease in patients with hypertension.
• Responsibilities:
• Imported data from Oracle Clinical Database and excel sheet into SAS by using SAS/Access and SAS/SQL.
• Created analysis datasets, tables, listings and graphs TLG's by reviewing statistical analysis plan and standard operating procedures.
• Performed validation of datasets, tables and listings produced by other programmers.
• Performed data cleaning using edit check programs for removing invalid data from the database.
• Extensively used SAS/BASE procedures like PROC MEANS, PROC FREQ, PROC UNIVARIATE etc. and SAS/STAT procedures like PROC ANOVA and PROC LOGISTICS.
• Created SAS customized reports using PROC TABULATE, PROC REPORT and DATA NULL .
• Created transport files for SAS datasets using PROC COPY.
• Involved in creation of DEFINE.PDF for FDA submission.
• Involved in creation of Integrated Summaries of Efficacy ISE and Safety ISS reports.
• Created reports in RTF, HTML and PDF formats using SAS/ODS.
• Utilized standard company macros and modified SAS programs for creating tables and listings.
• Created custom views combining data from multiple CRF's.
• Generated Ad-hoc reports for analyses using SAS tools for in the oncology therapeutic area.
• Worked with time, concentration and clinical pharmacology data and was involved in PK/PD data scrubbing removing invalid, out-of-range, missing or duplicate values , validation, data structuring and data integration.
• Documented the whole process for future reference.

Environment: SAS 9.1.3 Windows, SAS/BASE, SAS/MACROS SAS/ODS, SAS GRAPH, SAS STAT and MS-Excel.

confidential

Clinical SAS Programming Consultant

Description: Respa is a pharmaceutical company that is developing Respiratory relief products through Development, Manufacturing and Marketing.

Responsibilities

• Analyzed Phase II and III Clinical Trials through SAS programming and by providing statistical support to statisticians and Biostatisticians.
• Created CRT Case Report Tabulations datasets using ODM model of CDISC standards for submissions to the FDA.
• Successfully created Tables, Listings and Graphs using various procedures like Proc Report, Proc Tabulate, Data null, Proc Plot, and Proc Gplot.
• Created SAS Macros and modified the existing ones relating to multiple studies.
• Produced Tables, Listings and Graphs from Integrated Summaries of Efficacy ISE and Safety ISS .
• Effectively and timely contacted data management head of the respective study about the various Data Issues and resolved the queries through meetings.
• Maintained appropriate study application documentation.
• Performed Program Documentation on all programs, files and variables for accurate historical record and for future reference.
• Optimized performance using Data Validation and Data Cleaning on Clinical Trial Data.
• Involved in writing the SAS codes to help in the process of Quality control by implementing various statistical procedures like Proc freq, Proc means, Proc uni-variate and other procedures like Proc Summary, Proc Transpose, Proc SQL and Proc print.
• Successfully validated study TLG's and CRT's through independent validation using Proc compare and departmental standard macros.

Environment: SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/STAT, SAS ODS, Windows.

confidential

Clinical SAS Programming Consultant

Description: GSK is a pharmaceutical, Science-led global health care, researching on medicines for asthma, cancer, infections, mental illness, diabetes, cardiovascular and digestive systems and vaccines for debilitating diseases like HIV/AIDS, tuberculosis, malaria.

Responsibilities:

• Reviewed and provided input to documents such as eCRF, RAP outline, analysis dataset and display specifications and QC record.
• Performed statistical and data analysis, generated reports, graphs and listings using SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/SQL and SAS/ACCESS.
• Worked with the Clinical Data Management Group to design or review database structures.
• Integrated data from different studies and contributed in the preparation of Integrated Summary of Safety ISS for clinical studies.
• Developed routine MACROS to create Tables, Listings and Figures TLF's .
• Used DATA NULL technique for reporting outputs.
• Produced quality customized reports using TABULATE, REPORT and SUMMARY procedures and also provided statistics using procedures for MEANS, FREQ and UNIVARIATE analysis.
• Built new MACROS and modified existing MACROS to produce customized graphs using statistical procedures like PROC GPLOT and PROC GREPLAY to include in reports that required FDA approval.
• Responsible for QC of derived datasets and statistical results produced by other statisticians.
• Created HTML and RTF reports using SAS Output Delivery System ODS .
• Contributed to Case Study Reports CSR and documents to be submitted to FDA.

Environment: SAS/ODS, SAS/SQL, SAS/REPORT, SAS/GRAPH, SAS/BASE, SAS/MACRO, MS EXCEL, MS ACCESS.

confidential

SAS Programmer/analyst

Description: Globe Immune, Inc. is a biopharmaceutical company developing therapeutic vaccines for the treatment of cancer and infectious diseases. The products developed based on the tarmogens platform which activates the T-cell.

Responsibilities:

• Involved in clinical trial studies, data migration/extraction of data from Flat files, SQL Tables and SAS datasets.
• Created CRT Case Report Tabulations datasets using CDISC standards for submissions to the FDA.
• Extensively used Dynamic Data Exchange DDE for importing data in Excel sheets into SAS
• Extracted, validated and generated SAS data sets from Oracle applied 'SQL Pass through Facility'.
• Analyzed PhaseI, II and III Clinical Trials.
• Performed statistical analysis, wrote SAS code for Data Management and reporting, and performed validation, including testing SAS code.
• Produced Tables/Listings for Integrated Summaries of Efficacy ISE and Safety ISS .
• Communicated with Statisticians and Bio-Statisticians to discuss about various SAP related issues and made presentations to discuss about various possible changes in it.
• Maintained appropriate study application documentation.
• Used the SAS Macro facility to produce weekly and monthly reports.
• Performed Data Validation and Data Cleaning on Clinical Trial data.
• Created and maintained SAS Datasets that are extracted from an Oracle Clinical Database.
• Created SAS Customized Reports using Data Null technique for FDA regulations.
• Produced accurate, precise tables and listings for Clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations 21CFR Part11, FDA and other regulatory compliance.
• Developed routine SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Performed SAS programming using techniques as SAS Base, SAS Macro, data manipulation techniques, and statistical procedures e.g., Proc Means, Proc Freq, Proc Report .
• Extensive interaction with the functional users to understand the requirements on statistical methods and measures.
• Designed flowcharts indicating the input data sets and the techniques that would be used sorting, merging, etc. to get the desired output.
• Exposure to Data warehouse applications.
• Preliminary data validation clinical data quality checks is done on the clinical trial data using SAS/SQL.
• Produced data listings, summary tables and graphs for interim and final analyses and publications using different statements/function/procedure for data manipulation.

Environment: SAS/ODS, SAS/SQL, SAS/REPORT, SAS/GRAPH, SAS/BASE, SAS/MACRO, MS EXCEL, MS ACCESS.

confidential

SAS Programmer/analyst

Description: Bal Pharma is engaged in the business area of manufacturing Active Pharmaceutical Ingredients, Finished formulations and Ayurvedic Research and Development.

Responsibilities

• Involved in the analysis of Phase I and II clinical data.
• Performed data cleaning using Data Step and SAS Base Procedures.
• Generated summary reports and descriptive statistics.
• Creating and assigning user defined formats and labels to variables in analysis datasets.
• Generated tables, listings and graphs using MACROS, PROC TABULATE, PROC REPORT and PROC PRINT according to Statistical Analysis Plan.
• Performed data validation and corrections.
• Extraction, Cleaning and Validation of data from ORACLE tables.
• Writing analysis plans including specifications for tables, listings and figures.

Environment: SAS/ODS, SAS/SQL, SAS/REPORT, SAS/GRAPH, SAS/BASE, SAS/MACRO, MS EXCEL, MS ACCESS.