- SAS certified professional with experience in analyzing and coordinating clinical trial data, generating reports, tables, listings and graphs using SAS / SQL in accordance with the Statistical Analysis Plan(SAP), Standard Operating Procedures (SOPs) and departmental guidelines.
- Strong experience on Base SAS and MS SQL, SAS/Stat, SAS/Access, SAS/Graphs and SAS/Macros, SSIS and SAS/SQL in UNIX and Windows Environment.
- Data Validation and Data cleansing on Clinical Trial data using Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVARIATE.
- Generate reports using PROC REPORT, DATA NULL and PROC TABULATE
- Expertise in Data archival and Data migration, ad - hoc reporting and code utilizing SAS on UNIX and Windows Environments.
- Expertise in producing RTF, PDF, HTML files using SAS ODS facility
- CreateAnalysis Datasets, Summary Tables, Listings and Plots according to the specification of the study for statistical analysis
- Worked on Transact: SQL (DDL, DML, DCL)and in Design and Normalization of the database tables.
- Experience in implementing business logic using SQL Triggers, Indexes, Views and Stored procedures.
- Extensive Knowledge of advance query concepts (e.g. group by, having clause, union so on).
- Experience with tools like SQL Server management studio and SQL Server 2005/2008 integration (SSIS) and reporting services (SSRS).
- Proficient in Tuning SQL queries to improve the database performance and availability.
- Good knowledge in Normalizing and De: normalizing the tables and maintaining Referential Integrity by using Triggers, Primary and Foreign Keys.
- Expertise increating Packages using SQL Server Integration Services (SSIS).
- Familiar with the clinical data reporting in CDISC SDTM 3.1.2 format
- Familiar with CDISC conventions i.e., SDTM and ADAM models and hands on experience implementing them.
- Experience working with Oncology data and grading solid tumors using RECIST and CTCAE criteria.
- Accustomed to working in challenging environments under deadlines, excellent analytical, and problem solving skills
SQL TOOLS: SQL Server, Oracle, Sybase, Access, SQL, PL/SQL MS-OFFICE, WORD, EXCEL, POWERPOINT, ACCESS,PROJECT
SAS Tools: SAS V9.4, SAS/GRAPH,SAS/STAT,SAS/REPORT, SAS/ODS, SAS VIEWER, SAS LOG CHECKER
Analytics Languages: R, SAS, SQL and Python
Visual Analytics Tools: Tableau, TIBCO and Spot fire
Databases: Hadoop, Oracle, Sales force, Microsoft SQLand My SQL
Clinical Data Analyst
- Advanced knowledge of CI Clinical Data analysis and Quality measures by using analytical tools to summarize data in a meaningful and presentable format.
- Working on FDI project basically converting the SAS code to SQL code.
- Created and updated SAS programs for verification of CMS claims.
- Using technical skills to schedule reports and to produce user requested data templates/reports for user self-service reporting.
- Used SAS Reports, SQL, Excel and Access to perform the functions of data extraction and reporting.
- Wrote Stored Procedures to optimize queries and make reporting faster.
- Developed reports in the most efficient manner to process data for delivery to internal and external customers.
- Used both automated report generation and manual ad-hoc to extract and report data in either requested template formats or a user friendly readable format.
Environment:SAS, SQL Server, Oracle, Sybase, Access, SQL, PL/SQL, PQRS Registry, MSSP ACO, Clinical Integration(CI), Performance Quality Measurement Initiative (Core Measures).
SAS Clinical Programmer
- Utilized SAS Macros to develop tables, listings and figures. Extensively used PROC Reports to create listings and PROC graphs to create figures. Used SQL to convert Clindex data into SAS and for data manipulation.
- Involved in Statistical programming and validation of Analysis Datasets and Tables, Listings, Graphs (TLG'S).
- Worked on with different phases of Oncology clinical trials like Phase 1 and Phase2.
- Created Patient narratives and generated .XML outputs for FDA regulatory submissions.
- Worked closely with team Statistician and prepared Adhoc reports for analysis
- Created edit check programs to find data discrepancies in raw datasets
- Programed customized data displays, (including data listings, summary tables and routine graphics) in accordance with approved statistical analysis plan and shell displays for clinical research studies
- Successfully processed extremely large volumes of data into manageable SAS datasets for storage in an Oracle data warehouse
- Developed and analyzed clinical data as well as programming SAS codes to meet company and client standards.
Environment: SAS 8/9, SAS/BASE, SAS/MACROS, SAS/ACCESS , SAS/SQL, SQL Server, Oracle, Sybase, Access, SQL SAS/ODS, Excel/Access 2000, UNIX, Linux.
- Analyzed data using SAS Statistical Procedures such as Proc Means, Proc Tabulate, Proc Freq, Proc Summary.
- Created the analysis data sets by manipulating the data according to the specifications and annotated the Case report forms
- Generated listings and tables using PROC REPORT and PROC TABULATE, PROC FREQ AND PROC UNIVARIATE.
- Generated Summary tables and developed different types of statistical reports
- Extensively used company standard macros for effective and efficient outputs for clinical trials. Created study specific macros for better performance.
- Served as lead validator in clinical team environment: created and maintained validation notebook, participated in quality assurance (QA) charts and data review, interacted with team members and company clients, validated tracking forms and collected documentation from all support programmers. Responsibility also included validating work performed by others as well as analyzing team-programming plans.
- Prepared documentation with all datasets and variables within, including derived variables, and the project as whole
- Validating the datasets and comparing the results to that of source programmers output.
- Quickly gained a detailed understanding of the Protocol, Annotated CRF, Controlled Terminology, and raw datasets (extracted from the CDMS) for all studies assigned
- Keeping abreast of Protocol Amendments, updates to Annotated CRFs, updates to Controlled Terminology, and changes to Study Design impacting the raw datasets - address all changes that have an impact on the development of the SDTM in a timely manner - keep all Parties informed of these changes via the Issue Log and follow-up with an email to ensure that everybody is aware of the impending change.
Environment: SAS 8/9, SAS/BASE, SAS/MACROS, SAS/ACCESS , SAS/SQL, SQL Server, Oracle, Sybase, Access, SQL, SAS/ODS, Excel/Access 2000, UNIX.
- Gathering requirements
- Understanding various data sources and databases, and gaps in data to suffice the Business requirement
- Knowledge transfer to the Offshore team
- Data visualization and reporting
- Hypothesis testing, Predictive Model selection, developing Predictive solutions through various deep learning and Statistical algorithms.
- Solution delivery included the following phases: