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Hi
| Consultant Name |
City |
Availability |
Technology |
Relocation |
| Madhu R |
Quakertown, PA |
Immediately |
SAS Programmer |
Yes |
Professional Summary:
- SAS Certified Professional with 9 years of experience in Clinical and Pharmaceutical Industry. Experience in data analysis by using Clinical SAS includes detailed knowledge in all phases of clinical trials and good Command in statistical analysis and research, data management, programming, production of reports, tabulations, graphs, listing of clinical data, and robust knowledge of Base SAS, SAS/Macros, SAS/SQL, SASSPDS in both Windows and Unix Environment.
- Familiar with SAS 9.2 and 9.4 in SAS versions. Creation of new datasets from raw data files using import and infile techniques and modified existing datasets using SET, MERGE, UPDATE and CONDITIONAL statements.
- Good working knowledge on SDTM domains like Demographics (DM), Concomitant Medication (CM), Exposure (EX), Adverse Event (AE), Medical History (MH), Disposition (DS), Vital Signs (VS).
- Experience in cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.
- Strong experience using SAS/GRAPH to produce Graphs by employing SAS procedures such as Proc Gplot and Proc Gchart.
- Used SAS Macros extensively in the creation of new programs as well as the modification of existing programs to improve ease and consistency of results.
- Experience in producing reports, employing various SAS procedures like PROC SQL, PROC REPORT, PROC FORMAT, PROC FREQ, PROC PRINT, PROC MEANS, PROC UNIVARIATE and PROC SUMMARY and DATA _NULL_.
- Used base SAS procedures PROC FREQ, PROC SQL, PROC SORT, PROC Transpose and PROC MEANS to validate current results with expected results.
- Excellent programming skills in SQL and understanding of data management principles, such as joining data sets, data aggregation and sub-setting using PROC SQL.
- Experience in producing EXCEL, RTF, PDF, HTML files using SAS ODS facility.
- High proficiency in Understanding of clinical trial Study Protocol, Design document, SAP (Statistical Analysis Plan), and CRF/eCRF (Case report Form), annotated case report forms and company Standard Operating Procedures (SOP).
- Expertise in transforming data imported from disparate data sources into analysis data structures, using SAS functions, options, ODS, array processing, macro facility, and storing and managing data in SAS data files. Developed Patient profiles.
- Created SAS datasets (.xpt files) for electronic submission as per client requirement.
- Creation of XML-based metadata (the eXtended Mark-up Language) document is a standalone JAVA application that contains transmission, validation, and interpretation of data is prepared by the application of SAS tools.
- Creation of Case Report Tabulation Data Definition Specification (CRT DD) (Define.xml) is a document that FDA’s eCTD study data specifications required for drug submission in the SDTM format.
- Developed tables, listings and figures, for Clinical studies and prepared regulatory documents for FDA submissions.
- Generation of reports using proc Report and Summarizing clinical trial data according to the SAP (Statistical Analysis Plan).
- Good experience in Phase I to Phase IV Clinical Drug Trail studies. Understanding of clinical trial practices, procedures and methodologies.
- Knowledge of Clinical Terminology and regulatory Guidelines.
- Knowledge of regulatory requirements and Drug Development process.
- Knowledge of Clinical Data Interchange Standards Consortium (CDISC) process related to data standards including Study Data Tabulation Model (SDTM) and Analysis Dataset Models (ADaM).
- Generating SDTM and ADaM datasets using SAS as per sponsor specifications.
- Validating SDTM and ADaM datasets.
- Working Knowledge of CDISC, SDTM, International Conference of Harmonization, Good Clinical Practice (ICH GCP) and FDA guidelines.
- Understanding of SAS to evaluate a wide range of data types and to perform analyses according to analysis plans.
- Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
- Knowledge of ANOVA (Analysis of Variance) predictive model t-Test, one-way ANOVA, nonparametric one-way ANOVA, linear models and mixed linear model.
- Work assignment among the team and coordinate with study statistician and team to get work done with in timelines with quality deliverables.
- Good understanding of regulatory requirements relevant to submissions.
- Good knowledge of clinical trial study design and electronic data submission requirements.
- Knowledge of executing the test procedures and developing new computer programs.
- Highly self-motivated and goal-oriented professional to work independently as well as in a team environment.
Tools and Technical Skills:
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Statistical Software
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SAS v9/v9.2, SPSS
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SAS Tools
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SASV8,V9, SAS/BASE, SAS/SQL, SAS/Access, SAS/MACROS, SAS/GRAPH, SAS/STAT, SAS/Access, SAS/ REPORT, SAS/ODS.
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Languages
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HTML, SQL, XML
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Databases
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MS Access, SQL, SAS Clinical
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Office Tools
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MS OFFICE – Word, Excel, Power Point
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Operating Systems
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Windows / XP, Vista, Unix, Linux, Mac
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Thanks & Regards,
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