SUMMARY

• SAS Certified Clinical Programmer having over 8 years of experience in the IT industry with Prime focus on Clinical Research and Programming, Analysis, development, testing and implementation of Clinical Trial projects in Pharmaceutical industry using SAS
• Through knowledge in Clinical data and understanding of clinical trials.
• Worked on number of Phase 1, Phase II and few Phase III studies.
• Excellent command in producing reports employing SAS procedures as Proc Print, Proc Report, Proc Summary, Proc Freq, Proc Tabulate, Proc Means, Proc Univariate, Proc Transpose and Proc SQL.
• Good understanding of regulatory requirements, NDA processes, from IND submission to FDA approval.
• Proficient in clinical trials and related topics such as Study protocols, Review of Analysis plans and Specifications, Edit Checks, Analysis datasets, and Validation.
• Knowledge in generation of tables, listings, and figures
• Excellent command in producing reports employing SAS procedures as Proc Print, Proc Report, Proc Summary, Proc Freq, Proc Tabulate, Proc Means, Proc Univariate, Proc Transpose, Proc SQL.
• Developed SDTM data mapping and create SDTM domains per CDISC standard for FDA.
• Developed ADAM mapping specs and Domains based on SAP and TLF’s Shells.
• Ability to handle projects at every level, to perform Data validation Process and to prepare QC documentation.
• Highly experienced in the entire study life cycle starting from the source data review till the study close out and submission.
• Hands on experience in using SAS tools like SAS/BASE, SAS/MACROS, SAS/STAT,
• SAS/GRAPH, SAS/SQL and other.
• Familiar with 21 CFR Part 11 compliant statistical Process Control Systems, ICH, and
• Good Clinical Practice (GCP) guidelines, Controlled Terminologies, Coding Dictionaries such as MEDDRA and WHO DRUG.
• Good interaction with Clinical Data Management, Statisticians and Regulatory team members.

TECHNICAL SKILLS

• SAS, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT,
• SAS/GRAPHS, SAS/ACCESS and SAS/ODS
• SAS and SPSS
• MS Office (Power Point, Excel, Access, Word)
• Windows, UNIX

PROFESSIONAL EXPERIENCE

Confidential

Senior SAS Programmer/Analyst

Responsibilities:

• Processed the research data and converting into SDTM standard domains by following SDTM IG 3.1.2 and current CDISC Controlled Terminology documents by using base SAS.
• Developed dynamic SAS programs using SAS Tools like SAS/Base, SAS/Macros.
• Responsible for Developing reports for Safety and efficacy as per study requirements.
• Extensively used Proc SQL, Proc Transpose, Proc Format, Proc Means, Proc Univariate, Proc Freq, Proc Print and Proc Compare for checking the assumptions and conducting Statistical Analysis.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Annotated blank CRFs and mapped raw data for different Phases of clinical trials to SDTM datasets as per the CDISC SDTM guidelines.
• Generated SDTM compliant domains and SUPP QUAL and RELREC domains from the operational data and do the validation process.
• Generated reports in PDF, RTF or HTML formats according to the client specifications.
• SAS Macros were used extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables.
• Respond to ad - hoc request in timely manner.
• Perform any reconciliation process involves with the incoming data from external vendors like central and local lab data for the LAB, PK and ECG domains.
• Responsible for Merging the Coding reports from the latest Dictionary files (MEDDRA and WHODRUG) for AE, CM and MH domains.
• Created ADSL, BDS structure Efficacy and Safety analysis datasets as Per ADaM Standards using ADaM IG version 1.1.
• Experience with OPEN CDISC VALIDATOR TOOL for the validation process and maintain the issue log with resolution comments.
• Validated Fellow programmers output against to Specs using parallel programming and PROC COMPARE and some manual SAS or SQL scripts to check the data accuracy and consistency against to raw data.
• Extensively used statistical procedures like UNIVARIATE, MEANS, FREQ, GPLOTS and GCHARTS.
• Involved in generating and validation of Define.xml by using in house tool.
• Ability to write some common macros that are useful across multiple studies.

Environment: UNIX, Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, PROC Reports, MS-EXCEL, HTML and Windows.

Confidential

Clinical SAS Programmer

Responsibilities:

• Involved in SAS programming with Clinical Trials data for Phase I-III Clinical Trials in Oncology.
• Generated the Patient profiles to summarize all the Safety and Efficacy information for Oncology and CNS studies.
• Created Oncology specific efficacy analysis datasets like ADTTE and ADEFF from SDTM and other ADaM datasets.
• Generated Tables, Listings and provide QC check, validation of outputs for Oncology clinical trials.
• Created standard SDTM safety domains as per CDISC format and prepared analysis data sets (ADAM) for statistical analysis.
• Wrote SDTM QC Macros that validates the SDTM datasets against FDA standards.
• Ability to write some common macros that are useful across multiple studies.
• Generated tables, Listings and graphs using SAS.
• Generated reports in PDF, RTF or HTML formats according to the client specifications.
• Created ADaM datasets using SDTM datasets, ADaM specifications and SAP.
• Developed dynamic SAS programs using SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT.
• Writing specification document with mapping comment for SDTM domains.
• Created Efficacy and Safety analysis datasets as Per SDTM Standards.
• Perform any reconciliation process involves with the incoming data from out sources like central lab data for the LAB, PK and ECG datasets.
• Extensively used SAS STAT procedures for generating reports.

Environment: SAS/BASE, SAS/MACRO, SAS/STAT, SAS/ACCESS, SAS/ODS, SAS/SQL and UNIX, MS Office

Confidential

Clinical SAS Programmer

Responsibilities:

• Experienced in working all Phases of clinical studies.
• Worked on multiple therapeutic areas at the same time.
• Reviewed Protocol, Case Report Form (CRF) and Annotated CRFs.
• Worked on Annotation of Case Report Forms (CRFs).
• Reviewed raw datasets and validated the raw datasets against Annotated CRFs.
• Created programs for converting raw data sets into SDTM data sets using mapping specs.
• Effectively used many SAS functions like SCAN, SUBSTR, and TRIM.
• Used Proc Import for importing data from Excel sheets and CSV files.
• Created listings for Pharmacokinetic studies
• Generated listings and also validated listings for multiple studies.
• Developed Specification documents with clear mapping comments followed by CDISC SDTM standards and using SDTM IG and CDISC Control Terminology document.
• Involved in validating the fellow programmers work.
• Created need based ad-hoc reports to other team members

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