Swapna Patha

11+ years of experience in data analysis and statistical report programming in phase I - phase III of CDISC based clinical trials. Strong understanding of clinical trial data and extremely hands on in data step programming, manipulations, analyzing, and reporting of analysis results.

Experience in annotating Case report form (CRF) and table shells as per CDISC standards. Understanding the study related documents such as Protocol and SAP. Worked in different Therapeutic areas namely Neurology, Oncology and Gastroenterology. Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used time to time for SDTM and ADaM datasets and generating TLFs.

Experience in generating datasets and Tables/Listings and Graphs (TLG's) for Integrated Summaries of Safety (ISS) for FDA Submission. Performed QC of datasets and Tables, Listings and Figures (TLF) using parallel programming, output and code review. Proficient in writing maintainable, supportable and well-documented code.

Expertise in programming data imported from huge 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. Extensive knowledge of statistical procedures like PROC LIFETEST, PROC SUMMARY, PROC MEANS and PROC FREQ to get Binomial/Chi-square Fisher Exact test/Odds Ratio. Successfully handled responsibilities for Edit Checks and report generation.

Thorough knowledge and understanding of Code of Federal Regulations (21CFR) Part11, GCP, ICH, FDA and other regulatory guidelines. Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting. Works as a primary programmer for multiple Phase 1-4 studies.

Assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies. Independently develops analysis specification & programs. Identifies potential issues in study documentation and proposes solutions.

Contributes to strategic initiatives. Work independently on multiple concurrent projects. Effective team player with strong communication and interpersonal skills.

Sr. Statistical Programmer - Cytel - Cambridge, MA

(2023-05)

As a senior programmer, performed data exploration and analytics using healthcare data for Ad-hoc and recurring projects.

• Developed SAS macros, templates and utilities for data cleaning and reporting.
• Works as a primary programmer for multiple Phase 1-4 studies.
• Worked on CRF annotation as per client requirement.
• Developed Specifications for SDTM's, analysis datasets and TLF's annotations as per company and client standards.
• Developed Statistical Programs for analyses datasets, tables and listings for ISS and ISE.
• Developed SDTM and ADaM programming specifications in collaboration with Client and other clinical development colleagues.
• Generated SDTM's and analysis datasets like ADSL, ADAE, ADQS, ADEX, ADEFF and custom ADaM datasets as per Client standards.
• Used Standard Macros for generating Analysis Datasets, Tables, Listings and Graphs.
• Analyzed clinical trials data and generated Tables, Listings, and Graphs TLG's as per the Statistical Analysis Plan SAP.
• Performed validation of datasets and Tables, Listings, Graphs TLG's.
• Generated Graphs by employing SAS/GRAPH procedures including PROC GPLOT, PROC GCHART and created HTML, RTF, PDF reports using SAS/ODS.
• Used SAS/STAT procedures such as UNIVARIATE, FREQ, MEANS, GLM, ANOVA and LIFETEST.
• Using SAS Output Delivery system (ODS), generated reports in specific output formats like RTF, PDF, and HTML debugging and correcting the syntax and semantic errors in the code.

Sr. Statistical Programmer - IQVIA - Durham, NC

(2020-02 - 2023-04)

As a senior programmer, provided direction and oversight to programmers for creation of applicable deliverables. Performed data exploration and analytics using healthcare data for Ad-hoc and recurring projects.

• Developed SAS macros, templates and utilities for data cleaning and reporting.
• Worked on CRF annotation as per client requirement.
• Developed Specifications for SDTM's, analysis datasets and TLF's annotations as per company and client standards.
• Generated SDTM's and analysis datasets like ADSL, ADAE, ADQS, ADEX, ADTTE, ADEFF as per Client standards.
• Developed SDTM and ADaM programming specifications in collaboration with biostatisticians and other clinical development colleagues.
• Used Pinnacle 21 on SDTM and ADaM data for validation process and reports used for client submissions.
• Expertise in leading a project, maintaining timeline, and delegating work to resources.
• Experience in Resolving technical and data issues by asking resources, training, and mentoring to the colleagues.
• Used Macros for generating Analysis Datasets, Tables, Listings and Graphs.
• Analyzed clinical trials data and generated Tables, Listings, and Graphs TLG's as per the Statistical Analysis Plan SAP.
• Performed validation of datasets and Tables, Listings, Graphs TLG's.
• Generated Graphs by employing SAS/GRAPH procedures including PROC GPLOT, PROC GCHART and created HTML, RTF, PDF reports using SAS/ODS.
• Used SAS/STAT procedures such as UNIVARIATE, FREQ, MEANS, GLM, ANOVA and LIFETEST.
• Using SAS Output Delivery system (ODS), generated reports in specific output formats like RTF, PDF, and HTML debugging and correcting the syntax and semantic errors in the code.
• Handled TPV data like IRT, ePRO, Adjudicated committee datasets.
• Involved in client submissions and TPV external submissions like IDMC(Data Monitoring Committee) and Futility submissions.

Sr. Clinical SAS Programmer - QST Solutions, Ltd. (Abond CRO inc.)

(2016-01 - 2020-02)

As a senior programmer, developed SAS macros, templates and utilities for data cleaning and reporting.

• Developed Specifications for analysis datasets as per company standards.
• Generated analysis datasets like ADSL, ADAE, ADTTE, ADEFF as per Client standards.
• Wrote Statistical Programs for analyses datasets, tables and listings for ISS and ISE.
• Developed ADaM programming specifications in collaboration with biostatisticians and other clinical development colleagues.
• Led and supervised, created, implemented and executed import and export programs, in CDISC Compliant format.
• Involved in validation standard Macro, Macro development and documentation.
• Used Macros for generating Analysis Datasets, Tables, Listings and Graphs.
• Analyzed clinical trials data and generated Tables, Listings, and Graphs TLG's as per the Statistical Analysis Plan SAP.
• Performed validation of datasets and Tables, Listings, Graphs TLG's.
• Generated Graphs by employing SAS/GRAPH procedures including PROC GPLOT, PROC GCHART and created HTML, RTF, PDF reports using SAS/ODS.
• Used SAS/STAT procedures such as UNIVARIATE, FREQ, MEANS, GLM, ANOVA and LIFETEST.
• Using SAS Output Delivery system (ODS), generated reports in specific output formats like RTF, PDF, and HTML debugging and correcting the syntax and semantic errors in the code.

Clinical SAS Programmer - QST Solutions, Ltd.

(2014-07 - 2015-12)

• Extracting raw data from the warehouse and creating SAS data sets that are required for the project.
• Designed and developed project-specific SAS programs for biostatisticians, often producing analysis datasets, reports, or graphics.
• Involved in simple table programming like AE, CM, MH.
• Involved in complex table programming using different procedures like proc ttest, correlation, hazard ratio, pvalues etc.
• Involved in Listings and Graphs for phase I to phase IV trials.
• QC of table programing: involved in simple as well as complex tables QC to get familiarize with the company process.
• Extensively involved in the process of validation of Datasets and validation of Tables and Listings.
• Involved in Review of mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents.
• Extensively involved in Data cleaning and Edit checks and documented them.
• Extensively used SAS/ODS to produce HTML, PDF and RTF format files.
• Worked with biostatistician for statistical analysis and data managers for data cleaning.
• Worked on clinical data like Demographic data (DM), Lab data (LB), Vital signs (VS), Adverse events (AE), Pharmacokinetic concentrations (PC).
• Annotated CRTs and CRFs (Case Report Tabulations and Case Report forms) and Templates.
• Generated simple as well as complex SDTMs like AE, CM, MH, DM, SE, SV, FA etc.
• Involved in Annotation, Specs writing and QC of various SDTM datasets.
• Generated AD-hoc reports using print procedure.
• Validated the generated reports according to QC tracking sheet.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.

DTax (Portfolio Management) - NC Department of Revenue - Raleigh, NC

(2012-09 - 2013-08)

North Carolina Department of Revenue is a national model for revenue agencies. DTAX application is a Portfolio Management system which is a web interface.