KRISHNA SIVAKUMAR

• Spearheaded FDA, EMEA, and PMDA submission activities for Phase 1 and NONMEM programming team, ensuring global regulatory compliance
• Successfully implemented new FDA TQT guidance for TQT study in LEN submission and applied it to several cQT analyses.
• Pioneered the establishment of eSub Group in 2020 with a vision to bolster regulatory compliance and enhance efficiency of submissions
• Directed the team towards consistent submission package generation across various projects and TA, resulting in notable improvements in efficiency and speed of delivery
• Collaborated actively with data engineering team, devising utilities to automate functionalities, streamlining package generation processes
• Founded and is presently overseeing the PK Programming Group since Oct 2022, aiming to refine PKmerge and ADAmerge dataset generation
• Embarked on the development of PK data specifications and rigorous quality checks for late-phase studies, en- suring data accuracy and reliability
• Made impactful contributions to Firefly initiatives, focusing on Data Standards and Targeted Data Cleaning for PK datasets
• Assumed a pivotal co-lead role in the CDS-Clinpharm end-to-end optimization working group, delivering substan- tial value to all five workstream deliverables
• Engages in multiple working groups, including Early Phase full outsourcing, ECG Working Group and vendor selection, and Early Phase Biostats and programming, showcasing versatility and commitment to various aspects of clinical research.

• Oversaw all FDA and EMEA submission activities for Phase I studies, ensuring rigorous adherence to international regulatory standards
• Orchestrated both in-house and outsourced programming activities for Phase I studies across diverse therapeutic areas, streamlining operations and maintaining consistency
• Collaborated closely with the standards group to delineate PK-related domains and establish Phase 1 standards, thus fortifying data integrity and standardization
• Engaged proactively with statisticians and other clinical teams to determine specific requirements for ad-hoc analyses and agency RTQs
• Directed NONMEM programming endeavors for both exploratory and submission projects, guaranteeing optimal data analysis and submission readiness
• Embraced a leadership role in mentoring programmers, while strategically planning resources for forthcoming projects to ensure timely and efficient project execution.

• Directed both in-house and outsourced programming activities for Phase I studies across multiple therapeutic domains, ensuring consistent and high-quality results
• Collaborated proactively with the Clinpharm team to devise and implement a standardized specification document, institute rigorous quality checks, and formulate process manuals
• Authored an in-depth process manual that provides clear, step-by-step guidelines for diverse tasks, benefiting cross-functional teams
• Periodically assessed and revised existing processes, engaged stakeholders for feedback, and introduced en- hancements to drive efficiency and overall effectiveness
• Supervised NONMEM programming tasks for both exploratory and submission projects, upholding accuracy and regulatory compliance
• Launched and rigorously tested standard macros aimed at homogenizing processes for Phase I studies.

• Directed programming tasks for Phase I studies across diverse therapeutic domains, ensuring meticulous and standardized outcomes
• Engaged actively with statisticians and other clinical teams to conduct thorough analyses and produce outputs tailored to specific requirements
• Pioneered the establishment of the NONMEM Group in 2015, carving a niche in pharmacokinetic/pharmacodynamic modeling for enhanced drug optimization
• Assembled and steered a dedicated team focused on programming for modeling and simulation, empowering them to decipher and interpret intricate pharmacological data
• Assumed a mentorship role for junior programmers while actively engaging in Early Phase working groups, en- suring knowledge transfer and active participation in discussions
• Spearheaded the development of PK macro standards and set benchmarks for NONMEM specification standards, promoting consistency and best practices.

• Implemented Gilead’s ADaM mapping file macro, standardizing ADaM dataset creation across the Cardiovascular group, thereby improving data consistency and reliability
• Generated CDISC SDTM, ADaM datasets, and efficacy tables for three high-stake Phase III studies, bolstering data presentation and analysis
• Successfully created and validated ISE ADaM datasets and outputs for NDA Submission, ensuring accurate and timely submission
• Conducted several ad-hoc analyses to prepare comprehensive and convincing material for FDA meetings
• Coordinated programming activities for the River PCI project, providing technical guidance and solutions to team members, enhancing overall team performance.

• Pioneered the creation and validation of CDISC SDTM, ADAM files from non-standard data received from diverse sources, ensuring data standardization and accuracy
• Generated and validated safety and efficacy tables, listings, and graphs for Phase II and III studies, facilitating comprehensive and visually appealing data presentation
• Conducted thorough statistical analysis for key tasks including NDA, MAA submission, Advisory Committee Meet- ing, FDA Inspection, as well as for posters and presentations
• Successfully generated and validated integrated summaries (ISE/ISS) for NDA Submission, ensuring accurate and comprehensive data summation for regulatory purposes
• Reviewed and ensured the accuracy of statistical sections of the clinical study report for individual studies, ISS, and ISE
• Facilitated effective interaction with statisticians and other clinical team members, performed ad hoc analysis, and generated outputs tailored to specific requirements, thereby contributing to efficient teamwork and timely project completion.

• Managed all data management and programming activities with CROs, ensuring smooth collaboration and effec- tive project progression
• Created comprehensive SDTM, ADaM file specifications, datasets, SAS export files, and define.xml using CDISC formats for studies completed by various CROs, maintaining data consistency and quality across different studies
• Conducted meticulous QC for all study data received from the CROs both pre and post-database lock, ensuring data accuracy and integrity
• Implemented and made significant contributions to statistical analysis plans, mock-ups for tables, listings, and figures; reviewed Data Management Plan (DMP), Data Validation Plan (DVP), CRF design, and edit checks for Phase II studies, ensuring all aspects of the study were effectively planned and executed.

• Developed CRTs, ADaM file specifications and datasets, SAS export files, define.pdf, and define.xml using CDISC formats, optimizing the process for electronic submissions
• Served as the Primary Analyst for Integrated Safety Summary (ISS) and ISPK for critical Phase I Studies, ensuring high-quality data analysis
• Implemented standardized programs for Data Visualization across multiple cohort studies, enhancing data inter- pretability and presentation
• Fostered a collaborative environment with scientists, statisticians, data management, CRAs, medical monitors, medical writers, and regulatory groups, promoting seamless cross-functional communication and project progres- sion
• Provided expert guidance to team members on technical issues, ensuring quick resolution and minimal disruption to project timelines.

· Customize CRM applications (Clarify) and create reports

· Create edit check programs and resolved queries for data from patient bedside monitoring instruments for GE Medical sector.

· Programmed ad-hoc reports using SAS/BASE and SAS/GRAPH and supported programs that were used to transfer data to different systems.