Kirthi Rangaraju

Acting as Asset Lead for ID, HIV Projects with multiple studies overseeing all clinical programming activities.

• Reviewed sponsor eCRT packages for accuracy for completed NDA studies and supported future GSK submission planning.
• Established communication with stakeholders, negotiating QA strategy and arranging weekly status meetings with core team for project alignment.
• Highly involved in making key decisions to bring NDA approved studies to GSK Systems through Data Migration Plan and through DDF for ongoing Studies.
• Significant challenges with vendor eCRT packages overcame by regular communication with Sponsor vendor companies discussing issues and mitigation plan.
• Allocated resources efficiently to adhere to budget limits and project deadlines.
• Led studies implementing Agile Ways of Working (WoW) and initiated pilot projects to enhance innovation and project outcomes.
• Outsourced statistical programming work and represented the programming function in cross-functional meetings.
• Leading Clinical Programming Initiatives like Agile WoW Pilot, ADaM automation using AI, Biostats Acceleration to help study teams meet UQ timelines.
• Enhanced expertise in AI tools such as Gigi, Jules, and Copilot to optimize workflows within clinical programming.

• Led SAS teams for Phase I-IV clinical trials and FDA/MAA submissions, ensuring high-quality statistical programming and documentation.
• Coordinated statistical programming activities across multiple studies, ensuring timely and accurate delivery of DMC, BDR, IB, IA, CSR, and integrated analysis.
• Developed ADaM dataset specifications for studies and integrated summaries of safety and efficacy to enhance data analysis quality.
• Utilized Pinnacle 21 SDTM and ADaM packages to ensure compliance with industry standards and data review guidelines.
• Managed resources effectively, forecasting needs for personnel, finances, and technology to support multiple projects.
• Managed timelines and deliverables from FSPs/CROs across projects, ensuring alignment and accountability during weekly meetings.
• Oversaw employee performance through mentorship and guidance, enhancing team productivity and alignment with organizational objectives.
• Reviewed key study documents including SAP, case report forms, data management plans, and database specifications.

• Led core project team to coordinate and manage all statistical programming activities.
• Oversaw statistical support for clinical trials, facilitating ad-hoc analyses and ensuring data validation for accuracy.
• Utilized SAS software to produce formatted datasets, tables, and figures, enhancing data presentation for analysis.
• Developed and tested SAS programs for clinical studies, ensuring accuracy and efficiency.
• Generated TLFs using PROC FREQ, PROC MEANS, and PROC UNIVARIATE for robust statistical analysis.
• Conducted quality control to ensure output compliance with project requirements, collaborating with programmers and biostatisticians.
• Ensured adherence to relevant statistical regulatory guidance and departmental SOPs.
• Created and maintained programming tracking documentation to streamline project workflows and ensure compliance.

• Led SAS programming support for studies in inflammation and infectious areas, producing integrated analysis pools to enhance data accessibility.
• Oversaw programming plans and quality control documentation, standardizing extraction macros and QC processes to ensure compliance and accuracy.
• Designed and validated SDTM and ADaM structures to ensure accuracy in electronic submissions.
• Developed ADaM datasets and TLGs utilizing PROC FREQ, PROC REPORT, and other procedures.
• Leveraged SAS ODS for report generation in RTF, PDF, and HTML formats, enhancing documentation efficiency.
• Facilitated coordination meetings to resolve queries and align with project timelines, improving communication and clarity within the team.