PROFESSIONAL SUMMARY:

• Extensive experience in Statistical Analysis, Reporting and Clinical Data Management involving Analysis, design, development, testing and validating the applications.
• Experience in handling complex processes using SAS/BASE, SAS/MACROS, SAS /SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS.
• Proficient in CDISC standards and transforming raw data to create datasets following standards
• Experienced in creating and validating SDTM, ADaM datasets as per CDISC standards to support clinical trial analysis and reporting.
• Proficient in Importing or extracting data using Import techniques to create SAS datasets from various sources like Relational databases by connecting SAS System to database systems, such as Microsoft SQL, Oracle, Excel, flat files and Exporting data to generate dynamic reports in HTML, RTF, XML, Excel, and PDF formats by using SAS/ODS
• Programming experience with procedures like PROC DATASETS, PROC PRINT, PROC APPEND, PROC GPLOT, PROC GCHART, PROC COMPARE, PROC IMPORT, PROC EXPORT, PROC FORMAT, and PROC COPY.
• SAS as an ETL tool while Extract Transformation and Loading different data sets to SAS Datasets.
• Hands on experience in data management like Merging, concatenating, interleaving SAS datasets using MERGE and SET statements in DATA step and using PROC SQL.
• Creating new SAS Programs using SAS MACRO to improve ease and speed of modifications as well as consistency of results.
• Expertise in using SAS report generating procedures like PROC REPORT, PROC SQL, PROC TABULATE, PROC TRANSPOSE, PROC SUMMARY and Optimized performance using Data Validation and Cleaning on Clinical Trial data using statistical procedures like PROC FREQ, PROC ANOVA, PROC MEANS, and PROC UNIVARIATE.
• Proficient in performing QC on programs by developing Quality Control (QC) procedures
• Experienced in using R, Stata programming for Statistical Analysis and Data Visualization.
• Good knowledge of Drug Development Process including all clinical trial phases I - IV.
• Experience in Clinical Data Analysis in accordance with guidelines and providing Clinical Study Reports.
• Extensive experience as programmer in multiple therapeutic areas including Oncology, Infectious disease, Central nervous system, cardiovascular disorders.

PROFESSIONAL EXPERIENCE:

Confidential, Boca Raton, FL

Clinical SAS Programmer

Responsibilities:

• Provided SAS programming support to Bio-statisticians and data management team for analyzing clinical trial data and validation of tables, listings and figures.
• Responsible to develop, modify, validate and implement SAS programs according to Statistical Analysis Plan (SAP).
• Performing quality control of other programmers’ works and debugging complex programming code.
• Programmed edit checks to satisfy data collection, storage, and analysis for clinical studies. Created and validated programs in clinical trial initiatives, responsible for production of analysis datasets, data listings and summary tables.
• Experienced in Extract Transform and Load (ETL) from Source, OLTP Systems to Oracle MS SQL Database.
• Programmed DM listings.
• Working closely with team understanding Clinical Evaluation Reports for the Medical devices.
• Performed SDTM Validation Checks.
• Experienced in working on different types of Electronic Data Capture (EDC) techniques used in collecting Clinical Trail Data.
• Used R programming to perform Data visualization and reporting.
• Good experience with Stata as a Data Analysis and Reporting tool.
• Good understanding about safety Surveillance reports.
• Developed operational datasets, SDTM and analysis datasets.
• Assisted with Validation Analyst with SOP and Following FDA 21 CFR part 11 with Good Clinical Practices.
• Used SAS tools like PROC SQL to perform queries like join, create or manage datasets.
• Experienced in Source to Target Mapping in ETL using different types of Transformations.
• Validation of datasets and TLFs by parallel programming.
• Involved in programming and Quality Control checks for TLGs & ADaM (standard, non-standard and efficacy) including for ISS and ISE studies.
• Extensively used different SAS procedures such as Proc Means, Proc Univariate, proc tabulate, Proc Freq, Proc Compare, Proc Report, Proc SQL, Proc Transpose, Proc Summary, Proc Gplot and Data null step and other statistical procedures.
• Developed and validated standard and custom data listing, datasets, summary tables, and graphs as per requirement and standard protocols involved in study designs.
• Good understanding about Audit trails, working closely with Validation analyst.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Performed CDISC mapping using SDTM model and developed safety and efficacy reports.

Environment: CRF, SQL, ETL, SAS, MS Access, MS Office, CDISC, SDTM, ADAM, EDC, CDM.

Confidential, Durham, NC

Clinical SAS Programmer

Responsibilities:

• Converted SDTM datasets to XPT files to run Open CDISC Report.
• Worked on Open CDISC Report of SDTM datasets and addressed the “Errors and warnings” to create Error free data.
• Created directories and programs for startup studies as a lead.
• I have ensured to archive all documentation on studies after each delivery into proper folders.
• Did proper documentation for each deliverable by initiating signatures and archiving required documents based on SOP.
• As lead programmer always made sure we met first time quality and met client specified timelines by assigning task to different resources and double-checking quality of outputs on daily basis.
• Involved in Data review process by identifying data issues (BE checks) and being in touch with data validation team.
• Extensively handled MACROS and SAS Base procedures such as proc sort, proc print, proc means, proc FREQ, proc tabulate, proc transpose, proc compare, proc contents and proc format and proc SQL.
• Performed data analysis on data which was received every three weeks from client side and per the requirements generated the reports and participated in other clinical programming and data management activities
• Collected requirements from statisticians, prepared requirements document, follow up and developed new macros as per statistician’s request.
• Created SDTM specifications based on CDISC SDTM guidelines version 3.2 and updated existing SDTM programs based on request.
• Performed CRF SDTM annotations.
• Extensively worked on data mapping from existing raw dataset to CDISC SDTM data. Generated SDTM datasets for AE (Adverse Events) LB(Lab) MH (Medical History) VS (Vital Science) PE (Physical Examination) CM (Concomitant Medication)

Environment: CRF, Protocol, SAP, R, HP-ALM, SAS 9.4, CDISC, SDTM ADAM

Confidential, San Franscisco, CA

Clinical SAS Programmer

Responsibilities:

• Develop SAS code to create reports, listing and outputs from CDRG for clinical operations and data management teams to support data review for clinical studies.
• Act as a bridge between biostatistics and data management team by producing various listings in SAS and BO
• Conduct data validation for lab reconciliation and verification purposes to make sure records match between the data base and weekly lab transfers.
• Produce validation report comparing pre (vs) post data after global migration for all the studies.
• Perform randomization and stratification process review for all the studies to validate subject assignment in blocks.
• Work with datasets created according to SDTM standards.
• Generate AE/SAE, patient profile, medical history, concomitant medication, concomitant procedure and pharmacokinetics reports.
• Execute data manipulation and data cleaning using SAS skills such as creating new variables in SAS data step, data set merges, conditional statements, array, macro, ODS to output statistical procedures and SAS/SQL.

Environment: HP-ALM, SAS, CDISC, SDTM ADAM

Confidential, Tarrytown, NY

Clinical SAS Programmer

Responsibilities:

• Generated tables, listings with the help of SAS/BASE, SAS/ODS and SAS/STAT in windows environment.
• Provided programming needs to support client’s requirements.
• Used SAS for importing and exporting the data from and into SAS and Excel.
• Developed parallel codes to validate summary tables and listings.
• Performed source and validation programming on analysis datasets using SAS/MACROS and PROC COMPARE.
• Worked on creating analysis datasets, defined variables of interest, study populations, visit window and baseline observations.
• Generated summary table and listings for FDA submissions using PROC REPORT and SAS/ODS.
• Used LOCF (last observation carry forward method) to handle missing data values.
• Performing common analysis and obtaining statistics using PROC FREQ and PROC UNIVARIATE, PROC MEANS, PROC TRANSPOSE.

Environment: SAS, CDISC, SDTM, ETL, Data Integration, EDC, CDM.