Senior SAS Programmer - Clinical Trials & SDTM/ADaM Expert

TEJAS GUPTA

**************@*****.***

PROFESSIONAL SUMMARY

Certified SAS Base Programmer with 8 + years of experience as Sr. Statistical programmer and SAS Programmer Analyst in Pharmaceutical and CRO industries.

Excellent understanding and experience in clinical drug trials Phases I, II, and III.

Hands on experience in creating and validating Safety and Efficacy Table, Listings and Graphs.

Developed SDTM mapping Specification and created SDTM domains like DM, AE, EX, MH, VS etc.

Worked on SDTM versions V 3.1.2, V 3.1.3, and V3.2.

Experience in various therapeutic areas like Oncology, Rare diseases, Virology, Diabetes and Obesity.

Developed and validated SDTM and ADaM datasets for phase II/III Diabetes trials, including endpoints such as HbA1c, FPG, PPG and MACE and Hyperglycemic incidence.

Created and validated Oncology SDTM domains TU TR and RS.

Applied RECIST 1.1 criteria to derive standard Oncology endpoints such as best overall response, objective response rate (ORR).

Experienced in programming for ISS and ISE and submission level activities like reviewing define.xml/pdf, Reviewers guide and annotated CRF.

Created various plots like Kaplan Meier curve for Progression Free Survival, Waterfall plot, using GTL procedures and PROC SGPLOT using annotations facility.

Good understanding of various standards, criteria and dictionaries in clinical like CDISC, RECIST, NCI CTCAE, MedDra and WHODRUG.

Worked on Pinnacle 21 report and justified error, warnings, notes to include in Reviewer’s Guide.

Worked in conjunction with Data Management, Biostatistics and Clinical Operation teams.

PROFESSIONAL EXPERIENCE

Sr. Statistical Programmer

Gilead Sciences (Nov 2022– Present)

Provide SAS programming and statistical support to multiple Phase II and III clinical trials contributing to data analysis, report generation and regulatory submissions in accordance with study protocols and industry standards.

Develop and validated analysis datasets for safety and efficacy data.

Expertise in Macro programming to improve automation in dataset creation and reporting.

Provide SAS programming support to Biostatisticians in creating SDTM/ADAM datasets and TLF using CRF, SDTM IG, Mock shells, SAP, and Adam IG.

Created Line plots, Scatter plots, Histogram, Forest plot and other statistical graphs using Proc GTL methods to enhance data analysis and reporting.

Extensive experience in creating efficacy and safety TLF’s for planned and un-planned analysis.

Ability to collaborate across multiple departments such as Biostatistics, Clinical Operations, and Regulatory Affairs, focus on strategic goals.

Involved in improving programming process that enhanced quality in clinical trials.

Worked with Biostatisticians to generate safety and efficacy TLF by implementing advanced Statistical methods.

Generate ad-hoc for regulatory agencies and internal teams utilizing SAS/GRAPH for advanced plots.

Develop and validate tables, listings and ad-hoc queries generated by other statistical programmers.

Strong experience in mapping and submission of data in CDISC SDTM format, based on CDISC/SDTM implementation guide.

Generate reports on AE (Adverse event) and SAE (Serious Adverse events), Demographics, Laboratory shift and other safety and efficacy tables by referring to SAP and Mockup shells.

Create Integrated Summaries of Efficacy (ISE) and Safety (ISS) per FDA compliance.

Worked on Regulatory submissions like CSR, PBRER, and DSUR etc.

Utilized R programming for exploratory data analysis, statistical summaries, and data visualization to support safety and efficacy reviews alongside SAS deliverables.

Developed R-based visualizations and analyses (using packages such as ggplot2, dplyr, and tidyr) to complement SAS TLFs and support biostatisticians in data interpretation and decision-making.

Environment: SAS v9.4, SAS EG, Oracle, Windows and UNIX, Ultra Edit, BASE SAS, SAS /ACCESS, SAS /GRAPH, SAS /STAT, SAS /Macros, SAS /ODS, MS-Excel, Access

Sr. Statistical Programmer

Pfizer inc (June 2019 – Sep 2022)

Experience working in various studies from Phase II and III clinical trials to provide statistical programming support for SDTM, ADaM, TLFs.

Created and validated SDTM and ADaM mapping specifications using CRF, SDTM IG, Mock shells, SAP and Adam IG.

Proven expertise supporting various therapeutic areas like Diabetes, obesity and Oncology

Generated TLF’s for supporting Primary Glycemic endpoints like Hemoglobin A1c (HbA1c), Fasting Plasma Glucose (FPG), Postprandial Glucose (PPG) etc.

Worked on supportive end points including Glycemic Variability, Hypoglycemia incidence enhancing data clarity for efficacy and safety assessments in Diabetes trials.

Created and validated SDTM domains like DM, AE, EX, MH, VS and ADaM datasets ADSL, ADAE ADTTE, ADRS.

Experience in creating and validating various efficacy datasets like ADTTE, ADRS and worked on efficacy endpoints like time to event, objective response rate etc.

Applied RECIST 1.1 criteria to derive standard Oncology endpoints such as best overall response, objective response rate (ORR).

Created various plots like Kaplan Meier curve for Progression Free Survival, Waterfall plot, Forest plot.

Worked on multiple regulatory submissions like ISS/ISE.

Interacted with Bio-Statisticians, Data Manager, and other SAS programmers to provide ad-hoc and routine analyses and reports with regards to the assigned projects.

Worked with Sponsors to handle requests efficiently, ensuring timely TLF’s delivery.

Successfully managed communications to maintain strong relationships with sponsors and proactively addressed any logistic challenges to keep operations smooth.

Extensive experience in creating efficacy and safety TLF’s for planned and un-planned analysis (ad-hoc request from regulatory agencies and internal medical team).

Created and reviewed CRT (Case Report Tabulation) for submissions for accuracy of aCRF, define.xml.

Environment: SAS v9.1, MS-Excel, Access, Oracle, Windows and UNIX, BASE SAS, SAS /ACCESS, SAS /GRAPH, SAS /STAT, SAS /Macros, SAS /ODS

SAS Programmer

Dyne Therapeutics (Feb 2017 – Mar 2019)

Worked on phase II and III Oncology studies

Generated RTF, HTML and PDF outputs for clinical study reports and integrated summaries for regulatory submissions by using SAS ODS.

Involved in working with CRO’s/vendor companies as person of contact for study and address the issues from partners and make sure we get deliverables on target.

Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation

output, to be included in reports for submission to regulatory agencies, publications and other

communications.

Provided SAS programming support to Statisticians, Data Managers, and the Medical Writers to develop reports.

Write CDISC standard dataset specifications and follow specifications to create SDTM and

ADaM datasets.

Generated Safety and efficacy tables like Adverse Events, Demographics, Lab Shift and Progression Free Survival tables.

Communicated with Statisticians about various analysis dataset and TLG specification related

issues.

Involving in client conference calls if they needed data clarifications and understanding the standard formats.

Validated analysis datasets, tables, listings and ad-hoc queries generated by other statistical

programmers.

Validated and Developed Analysis datasets as per ADaM 2.1 standards, tables, listings as per specifications and mock-ups in SAP.

Wrote new SDTM specifications and verified already written specifications for the Analysis datasets.

Involved in the production and QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications and other process supporting documents

Environment: SAS v9.1, MS-Excel, Access, Oracle, Windows and UNIX, BASE SAS, SAS /ACCESS, SAS /GRAPH, SAS /STAT, SAS /Macros, SAS /ODS

EDUCATION

Master’s in Health Informatics, NYU

Bachelor of Science, RTMNU, India

CERTIFICATION

SAS Base Certified Programmer

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