Keerthana V
Professional Summary
Principal / Lead Statistical Programmer with 13+ years of pharmaceutical and clinical research experience supporting Phase I–IV studies, regulatory submissions, and cross-functional programming operations. Expert in SAS-based CDISC SDTM and ADaM dataset development, safety and efficacy TLF generation, and submission-ready deliverables including define.xml, SDRG, ADRG, and eCTD packages for FDA and EMA. Led a team of 15 statistical programmers across 12 concurrent clinical studies, driving timely delivery through standardized macros, independent QC workflows, and submission readiness reviews. Oncology programming background encompasses time-to-event analyses, response endpoints, and ISS/ISE pooled datasets. Experienced across oncology, cardiovascular, and health analytics domains with hands-on collaboration with Biostatistics, Clinical Data Management, and Regulatory Affairs. Brings a strong foundation in ICH E9, ICH E9(R1) estimands, and applicable FDA/EMA guidance to ensure scientifically sound, traceable, and compliant clinical programming deliverables.
Technical Skills
Work Experience
- Directed programming operations for three Phase III oncology trials, delivering 150+ CDISC-compliant SDTM and ADaM datasets and TLFs on schedule to support CSRs and regulatory submission packages.
- Architected reusable SAS macro libraries for ADaM derivations, TLF generation, and independent QC, cutting manual programming effort by 30–40% across the project portfolio.
- Developed programming specifications and R-based pooling approaches that reduced analysis cyclesbusiness days per indication, enabling earlier submission readiness.
- Led preparation and review of SDTM and ADaM Define-XML packages, ensuring accurate metadata, variable-level descriptions, controlled terminology alignment, and regulatory consistency for NDA/BLA deliverables.
- Provided statistical programming expertise for primary, secondary, and exploratory oncology efficacy endpoints — including response rates and time-to-event outputs — translating SAP requirements into reproducible SAS programs.
- Mentored a team of statistical programmers through technical code reviews, knowledge-sharing sessions, and implementation of project-level programming best practices.
- Delivered technology modernization initiatives by piloting R Shiny-based trial-monitoring dashboards alongside traditional SAS reporting workflows.
- Reviewed protocols, TLF mock shells, and oncology standards working-group specifications; partnered with Biostatistics and Clinical Data Management to resolve raw-data conversion issues and align deliverables with study requirements.
- Oversaw quality review of 100+ programming deliverables spanning CSRs, ISS/ISE packages, safety reports, and publications; independent QC identified and corrected 98% of programming errors prior to submission.
- Established standardized SAS macro libraries and programming methodologies for dataset derivations and TLF generation, reducing repetitive manual effort and improving consistency across concurrent studies.
- Guided Pinnacle 21 validation and automated define.xml production across 10 projects, measurably reducing submission rework and validation cycle time.
- Developed CDISC-compliant SDTM and ADaM datasets for ISS/ISE pooled analyses, ensuring methodological consistency of pooled datasets and reporting outputs across clinical studies.
- Backed safety and efficacy reporting outputs including adverse event summaries, laboratory summaries, abnormal vital-sign summaries, response summaries, and progression-free and overall survival analyses.
- Managed CRO and external vendor programming deliverables, coordinating review of specifications, resolving discrepancies, and maintaining quality and submission timelines across multiple concurrent studies.
- Facilitated alignment among Biostatistics, Data Management, and Clinical teams by evaluating alternative analytical approaches and communicating implications of programming and statistical decisions.
- Drove regulatory submission readiness reviews and QA audit discussions, addressing programming-related findings and ensuring documentation completeness for successful study delivery.
- Created and validated SDTM and ADaM datasets — including SDTM Plus datasets — using study specifications and CDISC standards, ensuring traceability from raw data through to analysis-ready outputs.
- Oversaw the development and validation of Define.xml, SDRG, ADRG, and annotated CRFs for NDA/BLA submission packages, ensuring metadata accuracy and regulatory compliance.
- Provided technical oversight of CRO and outsourced programming deliverables, verifying adherence to sponsor standards, programming specifications, and project timelines.
- Partnered with Clinical Data Management to review CRFs, annotated CRFs, edit checks, and database-lock readiness, strengthening data quality ahead of regulatory submission.
- Applied rigorous independent QC procedures — including dataset reconciliation, log review, and traceability assessments — to maintain accurate and reproducible clinical programming deliverables.
- Delivered ISS/ISE programming and reviewed submission documentation, including define.xml and reviewer guides, in support of global clinical pharmacology submission activities.
- Created and maintained define.xml for SDTM and ADaM and produced Define BIMO deliverables meeting FDA Bioresearch Monitoring Program requirements across multiple regulatory submissions.
- Generated XPT datasets for Pinnacle 21 validation, reviewed log warnings, and led resolution of validation findings to ensure submission-ready clinical data packages.
- Developed, documented, and validated SAS programs and reusable macros for standardized clinical data displays, reducing programming redundancy and improving cross-study consistency.
- Managed programming resources, project timelines, and delivery risks across multiple clinical studies, proactively addressing competing priorities and escalating critical cross-functional dependencies.
- Delivered clinical safety and efficacy reporting through programming and validation of adverse event, laboratory, vital-sign, exposure, and disposition analyses aligned with SAP requirements.
- Coordinated with external CROs, vendors, and programming teams to review specifications, monitor deliverable quality, and ensure adherence to programming standards and agreed timelines.
- Delivered SDTM and ADaM reviewer guides and global submission activities, working closely with Biostatistics and quantitative scientists to align programming with study analysis needs.
- Mentored team members and served as programming subject matter expert, providing technical support and guidance on complex dataset derivations and QC methodologies.
- Developed clinical analysis datasets, tables, listings, and figures using SAS to support CSRs, ad hoc requests, and regulatory reporting across Phase II and Phase III studies.
- Implemented oncology efficacy analyses including Kaplan–Meier outputs, progression-free survival, overall survival, and objective response rate using PROC LIFETEST and PROC MIXED in accordance with protocol-defined endpoints.
- Reviewed protocols, SAPs, and CRFs; annotated CRFs and mapped collected data to SDTM using CDISC standards and controlled terminology for submission-ready datasets.
- Maintained reusable SAS macros, programming utilities, and standardized TLF templates to improve programming efficiency and reproducibility across clinical studies.
- Backed audit and inspection readiness by maintaining traceable programming documentation, validation evidence, and submission-related records in accordance with applicable SOPs and regulatory expectations.
- Performed edit-check programming, peer validation, QC algorithms, and verification of analysis datasets against specifications to ensure statistical output accuracy and traceability.
- Mapped and standardized raw and legacy clinical datasets to the CDISC SDTM model, supporting electronic submission readiness for IND and regulatory reporting programs.
- Developed SAS data-step programs using functions and BY-group processing for data manipulation, complex derivations, and clinical reporting across health analytics and clinical trial datasets.
- Applied ICH E9, ICH E9(R1) estimands, and ICH E6 guidance to ensure statistically sound, traceable, and compliant clinical trial deliverables throughout a 4.5-year programming tenure.
- Created SAS reports using PROC SORT, PROC MEANS, and PROC REPORT; validated clinical research tables and supported data integrity and regulatory reporting requirements.
- Led and mentored statistical programming team members, providing technical guidance, code review, workload coordination, and quality oversight across multiple clinical studies.
- Partnered with clinical leadership and external statistical partners to assess study design considerations, evaluate analytical limitations, and communicate statistical findings to non-statistical stakeholders.
- Reviewed CRFs and study protocols, validated clinical data, and supported submission-related documentation to maintain data integrity and regulatory compliance across the portfolio.
Education
Certifications
Achievements
- Spot Award — Nov 2020: Recognized for outstanding project support and a high-performance mindset.
- Inspire Award — Oct 2019 and May 2020: Recognized for quality delivery and identification of QC issues during clinical programming reviews.
- Bravo Award — Feb 2016 and Sep 2016: Recognized for early delivery of high-quality datasets and demonstrated teamwork across clinical programming projects.
- Shout Out — Apr 2016: Recognized for delivery against timelines with quality and leadership across clinical study deliverables.
- Special Achievement Award — Apr 2014: Recognized for rapid understanding of organizational processes and contribution to clinical programming operations.
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