- Certified BASE SAS 9.2 Programmer and having around 5 of experience as a SAS Programmer with solid theoretical background in statistics and strong practical experience in data collection, manipulation and analysis using various statistical software applications in Pharmaceutical, CRO and Biotech industries.
- Experience in preparation of tables, listing and graphs using Base SAS, SAS/GRAPH and SAS/STAT.
- Extensive experience in using SAS Functions, Statements, Formats and Informats.
- Experience in design, writing and debugging the macro routines and applying macro variables in a SAS program.
- Good Understanding of Clinical Trial Protocols, CRF Annotation, Protocol Review, CRFs, Test Databases and Statistical Analysis Plans
- Worked on data validation and edit checks
- Good understanding of CDISC SDTM models and experience in converting legacy data to CDISC SDTM (Study Data Tabulation Model) Standards.
- Experience in Data mapping from non - CDISC SDTM to SDTM and creating ADaM datasets from SDTM.
- HTML, RTF and PDF formatted files using SAS/ODS
- Knowledge of CRF-Annotation with respect to various database designs in clinical trials for pharmaceutical industries.
- Strong SAS programming background for maintaining existing code, ad-hoc reporting and supporting the reporting functions.
- Good team player with excellent communication, analytical and problem solving skills.
- Extensive experience in Oncology and Cardiovascular therapeutic areas.
- Ability to work independently and in a team.
SAS Tools: SASV8.2,9.1, BASE/SAS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS MACROS and SAS/GTL
Procedures: PROC FREQ, PROC UNIVARIATE, PROC MEANS, PROC SORT, PROC REPORT, PROC TABULATE, PROC SQL and PROC PRINT
Languages: SAS, SQL
Databases: Oracle Clinical, Inform and MS Access
Operating System: WINDOWS VISTA, WINDOWS 7
Sr. Statistical Programmer
- Work on CDISC SDTM models and experience in converting legacy data to CDISC SDTM Standards.
- Used validation tools like Open CDISC Validator to check the compliance of CDISC SDTM ready datasets and prepared Reviewers Guide based on Open CDISC validator report to support the submissions.
- Extraction of the data from internal sources/importation of the data from external sources. These data are all imported into SAS and structured to meet our internal CDISC SDTM standards
- Experience in Data mapping from non-CDISC SDTM to SDTM and creating ADaM datasets from SDTM.
- Attend project team meetings, worked with Bio-Statisticians and Data Managers.
- Create SAS programs to generate Derived/Analysis datasets, Data Listings, Summary Tables, and Graphic displays according to company standards.
- Provided programming support, utilized and modified standard programs to generate reports in compliance with SOPs.
- Establish and maintain a sound working relationship and effective communication within Bio-statistics, Statistical Reporting and Data Management team. Also, coordinate and interact with other departments to ensure clean and accurate data, Quality Assurance standards and Data Validation.
Environment: Windows 7, SAS 9.2, SAS/MACROS, SAS/STAT, SAS/ACCESS, SAS/ODS, SAS/SQL.