LAKSHMI KOYA
Apex
Summary
Experience as SAS programmer in all phases of clinical trial data analysis and reporting. Have good knowledge and hands on experience of the clinical trial phases (I -IV), IND and NDA processes. Worked in Oncology, Immunology, Rare diseases, Ophthalmology, Respiratory, Nervous system therapeutic areas. Performed as a lead programmer and lead quality validator for many studies and managed resources. Experience in creating SDTM specifications and datasets as per CDISC guidelines. Skilled in Oncology domains like Tumor Identification (TU), Tumor Response (TR) and Disease Response (RS) and analysis datasets like ADPSF, ADRS according to specifications as per CDISC standards (SDTM & ADaM). Extensively worked on creating ADaM datasets like ADSL, BDS (ADRS, ADTTE, ADDA, ADLB, etc), OCCDS (ADAE, ADCM, ADMH, ADEX, ADCE, ADDS) following ADaM Implementation Guide. Experience in generating tables, listings and figures according to SAP and TLF specifications. Developed SAS macros for ADAM and TLG generation. Performed data validation and developed study specific edit checks specifications. Familiar with the creation of .XPT files (transport files), DDF files (Data definition) for E-submission. Good ability to work on multiple tasks and strong interpersonal, analytical, communication and problem solving skills and work independently as well as in a team. Create Define and Reviewers guide for SDTM and ADAM datasets. Followed 21 CFR part 11 FDA regulations, Standard operating procedures (SOP) and departmental guidelines. Worked with statisticians and clinical data managers to provide SAS programming in analyzing the data, generated reports, tables, listings and graphs. Experience in working with SAS ENTERPRISE GUIDE SOFTWARE and SAS STUDIO for reporting and analytical tasks.
Overview
14
14
years of professional experience
Work History
Senior Programmer Analyst
PPD Part of Thermo fisher Scientific
Morrisville
05.2013 - Current
- As a lead programmer and lead quality validator, involved in all study activities including safety and efficacy data from study start to study submission activities.
- Produce ADAM datasets based on Implementation Guide and Data specifications.
- Develop SDTM specifications, programs to produce SDTM datasets and check SDTM outputs against FDA rules by using Pinnacle 21 community tool.
- Produce tables, listings and figures according to SAP and TLF specifications.
- Provide Quality Control for derived datasets and outputs to ensure the output is 100% match after independent programming.
- Review of CRF, study protocol, database modification forms, data validation manual and SAP documents.
- Create specifications and develop data listings (DM listings).
- Perform extraction of raw datasets from different database like RAVE, OC and perform testing based on Study Design Specification (SDS), Trial Design Specification (TDS) and Functional Design Specification (FDS).
- Responsible for clearly documenting all work, managing assignments to meet timelines and producing high quality deliverables.
- Understand and follow department’s working practice, documents and SOPs.
- Communicate effectively with project team to complete assigned tasks on time and within budget.
- Function as a contributing member of a multi-disciplined team.
- Involved in validation of SDTM domains and also vendor imports validation.
- Create and maintain programs used for data entry, data management, data validation.
- Annotation of eCRF based on SDTM specifications and generate define.xml for regulatory submission.
- Act as mentor and first level escalation for Associate Programmer and Programmer Analyst.
- Assisted programming for ISS (Integrated summary of safety) tables and listings.
- Performed data checks as needed, to ensure integrity and correctness of data displays.
- Created transport files using SAS XPORT engine for SDTM data transfers to the clients.
- Created annotated CRFs, Define.XMLs, SDTM, ADaM reviewer guides.
- Implemented automated testing procedures to improve software reliability.
- Participated in project planning sessions to define timelines and deliverables.
Programmer Analyst
Medcore Pharma
Sommerset
01.2012 - 03.2013
- Created CDISC SDTM and ADAM datasets according with specifications.
- Extracted data using SAS Web tools.
- Worked with Data Cleaning and data validation on the work developed by other programmers in compliance with 21 CFR part 11 regulations.
- Used SAS MACROS programs to generate reports, tables and listings for clinical and bio-statistical review. Also used SAS MACROS to create new programs and modified existing SAS programs to make them portable as well as consistency of results.
- Used PROC GLM, PROC TTEST, PROC MIXED, PROC LIFTEST, and PROC CORR for Efficacy analysis.
- Efficiently produced Statistical summary Tables, Figures, and Listings (TFL’s) in accordance with Production standards and validation procedures.
- Used efficient programming techniques to produce QC derived datasets.
- Created specifications for demographic and adverse events datasets in accordance with Statistical Analysis Plan and Protocol.
- Generated various RTF, PDF files using SAS ODS system, exported and imported data from Excel files using PROC IMPORT and PROC EXPORT.
- Restructured SAS datasets using PROC TRANSPOSE for the analysis.
- Developed reports using PROC REPORT, PROC TABULATE and DATA _NULL_.
- Performed Quality Control and Quality Assurance on the work performed by others.
Education
General education classes -
Texas A&M Commerce University
Commerce, TX12.2011
Master of Science, M.S. - Chemistry
Texas A&M Commerce University
Commerce, TX01.2011
Bachelor of Pharmacy -
Nagarjuna University
India01.2008
Skills
- SAS/BASE
- SAS/STAT
- SAS/MACROS
- SAS/SQL
- SAS/ACCESS
- SAS/ODS
- SAS Procedures
- SAS Studio
- SAS Enterprise Guide
- Power BI
- R-Programming
Overall Summary
Experience as SAS programmer in all phases of clinical trial data analysis and reporting. Have good knowledge and hands on experience of the clinical trial phases (I -IV), IND and NDA processes. Worked in Oncology, Immunology, Rare diseases, Ophthalmology, Respiratory, Nervous system therapeutic areas. Performed as a lead programmer and lead quality validator for many studies and managed resources. Experience in creating SDTM specifications and datasets as per CDISC guidelines. Skilled in Oncology domains like Tumor Identification (TU), Tumor Response (TR) and Disease Response (RS) and analysis datasets like ADPSF, ADRS according to specifications as per CDISC standards (SDTM & ADaM). Extensively worked on creating ADaM datasets like ADSL, BDS (ADRS, ADTTE, ADDA, ADLB, etc), OCCDS (ADAE, ADCM, ADMH, ADEX, ADCE, ADDS) following ADaM Implementation Guide. Experience in generating tables, listings and figures according to SAP and TLF specifications. Developed SAS macros for ADAM and TLG generation. Performed data validation and developed study specific edit checks specifications. Familiar with the creation of .XPT files (transport files), DDF files (Data definition) for E-submission. Good ability to work on multiple tasks and strong interpersonal, analytical, communication and problem solving skills and work independently as well as in a team. Create Define and Reviewers guide for SDTM and ADAM datasets. Followed 21 CFR part 11 FDA regulations, Standard operating procedures (SOP) and departmental guidelines. Worked with statisticians and clinical data managers to provide SAS programming in analyzing the data, generated reports, tables, listings and graphs. Experience in working with SAS ENTERPRISE GUIDE SOFTWARE and SAS STUDIO for reporting and analytical tasks.
Therapeutic Experience
- Oncology: Aplastic Anemia
- Oncology: Leukemia
- Immunology: Cytomegalovirus infection
- Nervous System/Sense Organs: Alzheimer’s Disease
- Ophthalmology: Eye Diseases
- Respiratory: Asthma
- Endocrine/Metabolic: Diabetes Mellitus, Type 2
Prior Experience
General education classes with focus on a M.S. in chemistry, Texas A&M Commerce University, 40 credit hours completed including Thesis., 01/01/09 - 12/31/11
Professional Development
Certified with SAS Macro training.
Computer Experience
- Windows
- MS Word
- Word Perfect
- MS Excel
- Oracle Clinical
- MS
Timeline
Senior Programmer Analyst
PPD Part of Thermo fisher Scientific
05.2013 - Current
Programmer Analyst
Medcore Pharma
01.2012 - 03.2013
General education classes -
Texas A&M Commerce University
Master of Science, M.S. - Chemistry
Texas A&M Commerce University
Bachelor of Pharmacy -
Nagarjuna University