SUMMARY:

• Statistical Programmer / Analyst with 7 plus years of experience with strong emphasis in Clinical trials and thorough knowledge of Phase I-IV Clinical trials.
• Worked with Biostatisticians and Data management team to provide SAS programming to analyze data, generate reports, tables, listings and graphs.
• Significant track record in working on multiple projects and Strong interpersonal skills and ability to communicate clearly and effectively.
• Experience in developing Validating CDISC SDTM 3.1.2 datasets from raw data and Analysis data sets - ADaM format from SDTM datasets.
• Thorough knowledge of developing validating analysis datasets.
• Involved in preparing required documents for FDA submission such as ISS ISE.
• Experience in the preparation of tables and listings using Base SAS, SAS MACRO, SAS SQL and SAS STAT.
• Created reports in RTF and PDF format using SAS ODS.
• Expertise in RDBMS development using SQL. Conversant with data editing procedures for data corrections and data validation using SQL.
• Excellent problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels.
• Enthusiastic to develop new skills in a dynamic environment. Go-getter attitude and a great team player with solid leadership qualities. Always willing and ready to work hard and a very fast learner.

TECHNICAL EXPERTISE:

• SAS Tools: SAS V9.2, SAS V8.2, Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL.
• Operating System: Windows 95/2000, Windows NT, MS DOS, UNIX, Sun Solaris.
• Databases: Oracle 7.x/8, MS-Access 98/2000, Oracle Clinical.
• Packages: MS Office 97/2000, WordPerfect, Excel 97/2000, MS Project Developer 2000, Visual Basic 6.0

PROFESSIONAL EXPERIENCE:

Confidential

Senior Statistical programmer

Responsibilities:

• Created SAS datasets using CDISC Study Data Tabulation Model SDTM /ADaM Implementation guide for Statistical summaries and Analysis.
• Created tables, and listings according to the guidelines and specification of the client.
• Validation of analysis data sets, summary tables and data listings, as per the team specific QC procedures.
• Developed independent QC programs for validating the datasets and compared the values using PROC COMPARE
• Writing new specifications and verifying already written specifications for the SDTM Analysis datasets.
• Involved in Programming and QC for ISS/ISE.
• Involved in validation Patient profile vs. listings.
• Programming, planning and co-coordinating: i the programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries, ii the programming of database quality control checks, iii debugged macros and other programs to ensure cleanliness of log.
• Developing and planning programming documentation including plans and specifications, as appropriate.
• Performing and planning the development, implementation and validation of new process technologies, macros and applications coordinating with the lead statistician and the lead programmer.
• Providing advanced technical expertise in conjunction with internal and external clients, and independently brings project solutions to SP teams and the Statistical Programming department and participates in clinical project team meetings as required.

Confidential

Statistical Programmer 2

Responsibilities:

• Create analysis data sets, graphs, tables and listings for High Priority requests.
• Perform Safety, Efficacy for Interim analysis and Final analysis.
• Responsible for interacting with data management team, clinical team and submission team for various purposes.
• Worked with all kinds of Clinical Trials data such as Demographic data, Adverse Events AE , Serious Adverse Events SAE , Laboratory data Lab data , and Vital Signs.
• Involved in Programming and QC for ISS/ISE.
• Expertise in validating the documents before submitting to FDA.
• Developed SAS macros to create tables, graphs and listings for Clinical Study Reports and regulatory submissions.
• Prepared data listings for data management
• Created efficacy tables by using Analysis of Variance ANOVA , Proc REG, Proc CORR, Proc GLM, and Proc ANOVA.
• Writing new specifications and verifying already written specifications for the Analysis datasets
• Carried out Data Validation and Data Verification and provide code walk-thru for other team member codes.
• Created SAS datasets using CDISC Study Data Tabulation Model SDTM /ADaM Implementation guide 3.1.1 for Statistical summaries and Analysis.

Confidential

Associate Statistical programmer

Siro is the one of India's largest Contract Research Organization CRO carrying out research and development in Pre-Clinical, phase I-IV of Clinical Trials and Post-Clinical Trials for various pharmaceutical companies in US and abroad.

Responsibilities

• Developing and maintaining SDTM and Analysis datasets
• Prepared data listings and summaries for statistical analysis and analyzed clinical data using SAS procedures, including PROC MEANS, PROC FREQ, and PROC UNIVARIATE.
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS BASE and SAS Macro facility.
• Used SAS for pre-processing data, SQL queries, data analysis, statistical analysis and generation of reports.
• Wrote batch files for the automation of the complete study run process.