SUMMARY

• Over 6 years of experience working with SAS tools to provide solutions for Pharmaceutical companies/CROs on Clinical Trials.
• Extensively involved in Clinical Data Analysis and preparation of SAS Datasets, according to the Standard Operating Procedures SOPs and departmental guidelines.
• Strong working knowledge of Base SAS, SAS Macros, SAS GRAPH, SAS STAT, SAS/SQL, CDISC, SDTM, ADaM, familiar with both Windows and UNIX environments.
• Extensive experience in Clinical Data Analysis, preparation of SAS Datasets, reports, tables, listings, summaries and graphs according to the Statistical analysis Plan SAP , Clinical Protocol, CDISC standards, and Electronic Submission standards.
• Thorough knowledge in Clinical Data Analysis using Oracle Clinical, Clintrial and SAS.
• Experience in data transformations edit check and commanding experience in analyzing Case Report Form CRF data.
• Thorough knowledge of Clinical trial data like Demographic data DM , Vital signs VS , Adverse Events AE , Laboratory data LB including PK/PD, Efficacy and Safety data.
• Experienced in taking over other programmers and validation.
• Used SAS macros to generate listings and tables for the study reports for IND, NDA submissions in compliance with 21CFR Part 11 FDA regulatory guidelines.
• Have worked closely with Biostatisticians/Data Managers in analyzing the Clinical Trial Data and generating Integrated Summaries of Efficacy ISE and Integrated Summaries of Safety ISS tables, listings and graphs for FDA submissions.
• Generated output files in RTF, HTML and PDF format using SAS ODS.
• Experience in therapeutic areas of Respiratory, Oncology, Virology, and Central Nervous System.
• QC and validation using PROC compare and developing programs in parallel.
• Excellent communication skills, analytical, interpersonal, presentation, problem solving skills and ability to work in a team or independently.

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Sr. Stastical Programmer

Confidential

Responsibilities:

• Developed SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets.
• Involved in the mapping process for creating CDISC SDTM domain datasets from existing clinical trial data using annotated CRFs and SDTM IG and DDTs.
• Involved in development of different analysis datasets ADaM using SDTM datasets as per Statistical Analysis Plan SAP .
• Involved in the preparation of Data definition tables DDTs /specifications, Define.pdf and other project management documents.
• Produced statistical tables, listings, and figures for individual and integrated reports involving both safety and efficacy analysis based on the SAP and mock shells.
• Developed efficient, well documented, readily comprehensible, modifiable and reusable SAS programs using Base SAS and SAS Macros.
• Involved in validating analysis datasets, Tables and listings and also documenting the findings and comments using the endorsed tools in an efficient manner.
• Provided input into planning documents such as validation plan, statistical analysis plan, and TFL templates. Generated necessary outputs required for CSR's clinical study reports , integrated summaries and electronic submissions.
• Worked with Data Cleaning and data validation on the work developed by other programmers in compliance with 21 CFR part 11 regulations with the use of PROC SQL and PROC COPY for XPT files.
• Involved in PK analysis and worked on edit checks, PK tables, PK listings.
• Developed reports using PROC REPORT extensively.
• Also provided descriptive statistics using PROC MEANS, PROC FREQ and PROC UNIVARIATE.
• Demonstrated ability to organize workload and priorities, to work effectively in a team environment and contributing to all project management such that timelines are met.

Environment: Windows XP, SAS V9.1, MS Excel, SAS SQL, SAS Macro, SAS GRAPH, SAS ODS, SAS STAT

SAS Programmer

Confidential

Responsibilities:

• Responsible for providing SAS programming support for phase I, II clinical trials.
• Responsible for the proper Coding, Documentation and Validation of programs/macros to produce the standardized data displays.
• Converted existing raw data into SDTM IG 3.1.2 and reviewed CRFs Case Report Form to ensure the consistency and adequacy with the protocol requirements.
• Worked on different SDTM domains such as Demographics DM , Adverse Events AE , Serious Adverse Events SAE , Vital Signs VS , Prior Medication Data and Lab Data LB .
• Applied mapping logic for creating SDTM domain datasets and involved in validation of loading to SDTM domains.
• Wrote specifications and developed several analysis datasets ADaM such as ADSL, ADCM, ADLB and ADAE etc.
• Prepared Safety and Efficacy summary results with Tables, Patient Data Listings, Graphs/Box Plots and Reports for company's clinical trials using PROC SQL, PROC REPORT, PROC MEANS, PROC FREQ and PROC GPLOT.
• Converted .sas files to .txt files for the purpose of FDA submission.
• Generated Macros to create graphs, listings, quality tables for clinical study report CSR and regulatory submissions.
• Produced many AD-HOC reports, as requested by statisticians to satisfy and verify many of data and SOP issues.
• Performed QCs and Validation using PROC COMPARE and reviewed the proc report of developer.
• Experience in creating lab shift tables.
• Used ODS facility to create listing outputs like HTML, RTF, PDF files.
• Reviewed and provided input on the design of SAPs including specifications for tables and listings.

Environment: Windows, Base SAS v8.2, SAS v9.3, SAS Macro, SAS GRAPH, SAS STAT, SAS ODS, SAS SQL,SAS ETL, MS Excel.

SAS Programmer

Confidential

Responsibilities:

• Providing SAS programming and Analysis support for early development group, phase 1 oncology clinical drug trial.
• Responsible for developing new SAS programs and modifying existing programs and creating new listings and graphs.
• Participated with early development of the cancer drug in producing the tables and graphs.
• Generated tables and listing for demographic and adverse events for all grades.
• Generated death and reason for discontinuation tables and helped in the analysis of the output of the drug with the help of the bio-staticians.
• Participated in the PPd meeting and early development of the drug.
• Reviewing of the protocol, Sop and CRF under the guidance of the bio-statician and science group.
• QC program generated by the other developer for safety analysis.
• Imported and exported data from other data sources such as Excel.
• Involved in Statistical aspects of Clinical Trials, experimental design, data analysis, summarizing and reporting.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Wrote statistical sections of Clinical Study Reports and assisted in preparing integrated Clinical / Statistical reports.
• Tested and debugged against the test data before the interim or final Data Base locks.

Environment: Windows, SAS 8/9, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ODS, Excel/Access 2000.

SAS Programmer

Confidential

Responsibilities:

• Assisted in providing SAS programming in the data analysis of phase I, II clinical trials.
• Created and maintained SAS datasets that are extracted from an Oracle Database.
• Extensively used SAS BASE procedures such as PROC IMPORT, EXPORT, PRINT, TABULATE, REPORT, SQL, MEANS etc.
• Used Base SAS functions like ROUND, SCAN, TRIM, LENGTH, PUT, INPUT, DATE, MAX, MIN, MEAN and STD etc. .
• Used SAS STAT for descriptive statistics analysis, Frequency distributions and to present results in histograms and box-plots.
• Involved in creation of tables shells for SAP.
• Developed standard reports for Safety Efficacy data including laboratory and adverse event summaries for IND Investigational New Drug .
• Assisted seniors and fellow programmers in validation, edit checks and data review listings.
• Worked on ad-hoc analyses as per user's guidelines and requests.
• Created basic statistics using PROC MEANS, PROC SUMMARY, PROC UNIVARIATE, PROC FREQ.

Environment: SAS V8.2 SAS Base, SAS Macro, SAS ODS, SAS GRAPH, SAS SQL, Oracle, Windows NT.