Hi, I’m
Luxmi Gupta
Cary,NC
Overview
12
years of professional experience
1
Certification
Work History
Mckesson
Sr. Statistical Programmer
06.2017 - Current
Job overview
- Create and review annotated CRF to SDTM datasets
- Responsible for the translation of the SAP into programming specifications for analysis data model (ADaM) datasets
- Review and provide input on key study-related documents produced by other functions, such as case report forms, data management plan, statistical analysis plan and TFL specifications
- Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standards (custom study specific) datasets as defined in specifications documents
- Responsible for the development, review, validation, and execution of SAS programs to generate presentation-ready outputs (i.e., Tables, Figures, and Listings), as defined in the statistical analysis plan
- Review of statistical output and clinical study reports
- Ensure accuracy, quality, and timeliness of all work completed for the project.
- Communicate effectively within a multi-disciplinary project team and external resources to complete assigned tasks on time and within budget
- Responsible for accuracy and reliability of results. Function as study lead programmer on one or more clinical trials:
- Provide guidance in programming for analysis tables/figures, appropriate procedure/method selection for advance statistical analyses
- Ensure all programming activities on the study adhere to required standards
- Provide input to and participate in team meetings
- Work closely with the client and project statisticians to ensure that all project milestones are communicated, tracked, and delivered within agreed upon planned timelines
- Carry out all activities according to company SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP)
- Adapts to changing circumstances, policies, work assignments, and/or team members.
- Able to multi-task and prioritize workload with limited supervision
InVentiv Health
Sr. Statistical SAS Programmer
05.2016 - 04.2017
Job overview
- Act as the Sr. statistical programmer and coordinate, manage all statistical programming activities.
- Provide statistical programming liaison with the client and input for SAPs.
- Create and maintain programming tracking documentation.
- Create, test and maintain SAS programs for clinical studies.
- Generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan.
- Generate outputs and reports to support other departments.
- Deliver ad hoc requests in fast paced medical affair team.
- Perform validation on computer-generated output to verify accuracy.
- Create TFLs from raw data
- Perform critical data checks for the data base lock
- Transfer of deliverables.
- Following departmental SOPs, OGs and relevant regulatory guidelines (e.g. ICH).
PPD
Statistical SAS Programmer
08.2013 - 05.2016
Job overview
- Used CDISC standards and created DDS (Data Definition Specifications) for SDTM and ADaM datasets and wrote SAS programs accordingly
- Used lookup tables to assign controlled terminology across different studies.
- Created macros for reporting and coding of complex data analysis logic like, Windowing and LOCF
- Collaborated in programming for ISS (Integrated Summary of Safety)
- Worked closely with Biostatistician consultant and Data Management groups to ensure project operated smoothly
- Produced tables, listing and graphs and derived analysis datasets according to SAP
- Created transport files (XPT files) for submission to FDA
- Managed deadlines and progress of the study using trackers
- Produced Safety and Efficacy TLF (Table Listing and Figures) as per SAP (Statistical Analysis Plan) and Mock Shells.
- Annotated (Case Report Form) to Version 1.1 and 1.2 of SDTM standards
Education
Maharshi Dayanand University
Bachelor Degree from Education (B.ED.)
University of Delhi
Bachelor Degree from Arts (B.A.)
Skills
- Clinical SAS programming skills
- Dataset creation and analysis
- Data validation expertise
- Study design understanding
- Statistical analysis plans knowledge
- CRF annotation proficiency
- SDTM/ADaM specification writing
- Macro development for consistency
- Quality control processes in datasets
- SAS experience in UNIX/Windows environments
- Project handling under changing priorities
- Customized report generation
Certification
- Certification in Clinical SAS Programming SAS Global Certification, USA
- Base and Advance SAS Programming Wake Tech Community College, USA
- Base and Intermediate SQL
- Introduction to Java
- Microsoft Office Application Certificate (Word, Access, Excel)
- Introduction to Networking
Timeline
Sr. Statistical Programmer
Mckesson
06.2017 - Current
Sr. Statistical SAS Programmer
InVentiv Health
05.2016 - 04.2017
Statistical SAS Programmer
PPD
08.2013 - 05.2016
Maharshi Dayanand University
Bachelor Degree from Education (B.ED.)
University of Delhi
Bachelor Degree from Arts (B.A.)
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