SUMMARY

• Statistical Programmer/ Analyst with 8 plus years of experience with strong emphasis in Clinical trials and thorough noledge 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 (TLG).
• Plans in preparation for the programming of the Data Quality Review Plan (DQRP) and the safety and efficacy tables, listings and graphs (TLG) required for the Clinical Trial Report (CTR) and the associated Analyses Data Sets (ADS).
• Produce well documented validated standard and non-standard edit check and monitoring programs to support the clinical trial team to ensure the integrity, accuracy and completeness of the data in preparation for clinical reporting.
• Provide support for the electronic submission to regulatory agencies worldwide
• Help maintain libraries of fully documented and validated programs, macros andprocedures which can be reused by other programmers to aid in the efficiency for the department
• Significant track record in working on multiple projects and Strong interpersonal skills and ability to communicate clearly and TEMPeffectively.
• ADaM format from SDTM datasets.
• Thorough noledge of developing & validating analysis datasets.
• Involved in preparing required documents for FDA submission such as ISS and 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.
• Utilize SOP’s and guidelines, trail protocol, annotated case report forms(CRF), oracle clinical study definitions, trail and project data handling rules and standards and statistical analysis.
• Review the programming specifications and table mockups in the Trial/Project/Substance Statistical Analyses Plan (T/P/S/SAP) for completeness, correctness and adherence to sited department guidelines and SOPs
• Hands on experience in Data Mining.
• 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 SKILLS

SAS Tools: SAS V9.4, SAS V9.3, 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: SPSS packages, MS Office 97/2000, WordPerfect, Excel 97/2000, MS Project Developer 2000, Visual Basic 6.0

PROFESSIONAL EXPERIENCE

Confidential, CA

Sr. Statistical Programmer

Responsibilities:

• 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, iv) data mining.
• 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.
• Created SAS datasets using CDISC Study Data Tabulation Model (SDTM) /ADaM Implementation guide for Statistical summaries and Analysis.

Confidential, NJ

Sr. Statistical Programmer

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.
• Used SPSS for data extraction and exploration followed by analysis using SAS.
• 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

Sr. Statistical programmer

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

Confidential

Sr. Statistical programmer

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

Confidential

Statistical Programmer

Responsibilities:

• Create analysis datasets, tables, and listings according to the guidelines and specification of the client
• Created data sets in SDTM 3.1 format and created analysis data sets based on ADAM specification.
• Validate analysis datasets, tables, listings and ad hoc queries generated by other statistical programmers
• Coordinating with the lead statistician and the lead programmer
• Created Analysis data sets, Tables, Listings for ISS and ISE.
• Develop reports using PROC REPORT.
• Perform program documentation on all programs, files and variables for future reference.
• Program all study-specific edit checks and review listings.
• Performed SAS edit checks on raw data
• Retrieved oracle tables using SQL pass through facility