SUMMARY

• Around 6 years of experience in Software Industry.
• 5+ Years of experience in SAS Programming in a CRO and Pharma, specialized in Clinical trials.
• Experience in biometrics for data analysis of Clinical trial data.
• Extensively used SAS Macros, Graphs for clinical/ statistical report.
• Extensively used SAS SQL for report generations.
• Preparation of clinical/ statistical report for regulatory submission.
• Generating Summary Reports. Tables for safety and efficacy analyses.
• Very good understanding of CDISC SDTM, ADaM models and experience with conversion of legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
• Expertise in creation of user defined macros.
• Knowledge in Microsoft Excel, SQL, COBOL, C, C++.
• Experienced in creating and developing guidelines for annotating blank crfs in accordance with CDISC standards
• Experienced with summarizing and interpreting data from Phase I - III Clinical Trials in the various therapeutics areas like Diabetes, Psychology, Oncology and Hematology etc..
• Experienced in preparation of SAS datasets and creation of Tables, Listings, Graphs, and Reports using Output Delivery System (ODS)
• Standard Operating Procedures (SOPs), and the Statistical Analysis Plan (SAP).
• Experienced in design/creation of TLG requirements using MS Word.
• Experienced with data integration for ISS/ISE submissions.
• Experienced in data manipulation procedures such as SAS Formats/Informats, Merge, Proc content, Proc Sort and Proc Transpose.
• Experienced in using SAS procedures like Proc Print, Proc Report, Proc Mean, Proc Univariate, Proc Freq, Proc Transpose, and Data NULL to create reports/summaries.
• Experienced in validating SAS Datasets, Tables, Listing and Figures using proc compare procedure.
• Experienced in Programming Edit Checks.
• Experienced with importing and transforming data in various formats (Excel, Access, CSV) into SAS datasets.
• Excellent understanding of Study Protocols, SAP (Statistical analysis plan), and CRFs.
• Excellent written and oral communication skills
• Exceptional ability to work independently and within a team
• Ability to multi-task and think logically in stressful situations
• Excellent leadership and organizational skills

TECHNICAL SKILLS

SAS Tools: SAS/BASE, STAT, GRAPH, ODS, MACROS, SQL, and ACCESS

Platforms: WINDOWS 95/98/2000/NT/XP and UNIX

PROFESSIONAL EXPERIENCE

Confidential, NJ

Clinical Programmer

Responsibilities:

• Produced Tables, listings and graphs for interim and final analysis.
• Extensively used departmental macros to create Derived datasets, TL’s.
• Provided data in SAS transport files, Define documents, Patient Profiles.
• Worked on ISS safety study. Integrated several protocols and created safety reports.
• Performed validation programming on clinical trial data using SAS MACROS.
• Created formats to setup the treatment codes and used in all the reports.
• Knowledge in ISPF editors and NEditor under UNIX environment.
• Produced AD-HOC reports Medical Monitoring.
• Performed quality controls (QC) on SAS programs.
• Performed Quality review (QA) on safety tables against listings
• Created PK/PD Listings and reconciliation listings for Phase 1
• Maintained all project related documents in DOCMAN.
• Created format libraries

Environment: SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, SAS/ODS, SAS Formats, UNIX, ISPF.

Confidential, KS

Statistical Programmer

Responsibilities:

• Worked in various therapeutic areas
• Created SDTM datasets
• Creating Derived datasets from raw datasets
• Creating Tables and Listings and Graphs
• Validating Datasets, Tables, Listings, Graphs
• Created Define document and SAS transport files biometrics for data analysis of Clinical trial data.
• Extensively used SAS Macros, Graphs for clinical/ statistical report.
• Extensively used SAS SQL for report generations.
• Preparation of clinical/ statistical report for regulatory submission.
• Generating Summary Reports. Tables for safety and efficacy analyses.
• Very good understanding of CDISC SDTM, ADaM models and experience with conversion of legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
• Expertise in creation of user defined macros.
• Experienced in creating and developing guidelines for annotating blank crfs in accordance with CDISC standards
• Experienced with summarizing and interpreting data from Phase I-III Clinical Trials in the various therapeutics areas like Diabetes, Psychology, Oncology and Hematology etc..
• Reading SOP’s and understanding protocols

Environment: SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, SAS/ODS, SAS Formats, Windows.

Confidential

SAS Programmer/Lead SAS Programmer

Responsibilities:

• Creating derived datasets from raw data
• Writing SAS programs for tables, listings, graphs
• Creation of Annotated PDF
• Writing Specifications for Datasets, Safety Tables and Listings.
• Writing standard macros and creating macro library
• Writing standard formats and creating format library
• Creation of Analysis Data sets and Validation.
• Extensively used Base SAS, SAS Macros, and SAS Graphs.
• Used Proc Report for table generation.
• Provided data in SAS transport files, Define documents, Patient Profiles.

Environment: SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, SAS/ODS, SAS Formats, Access, Windows.

Confidential

SAS Data Programmer

Responsibilities:

• Maintaining and Review of all the Data Entry and edit checks document.
• Development of Clinical Database Management System.
• Designing and Tracking CRF pages
• Data entry, Tracking data
• Creation of SAS datasets
• Writing edit checks
• Annotated CRF
• Extensively used SAS/ACCESS

Environment: Visual Basic, SQL server, Access, Windows, SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT.

Confidential

Admin

Responsibilities:

• Maintain documents
• Creating reports
• Notifying the Students and parents
• Extensively used Excel and MS Word