Karthik Darbha

About Karthik Darbha

Successfully implemented projects that required development of new methodologies for Planning, organization and controlling project activities.Highly intuitive in the skilled use of technology and effective application of human capital to achieve key business objectives.Managed an experienced group of SAS programmers to support the management of the clinical development programs in the immuno-oncology,CV Therapeutic areas, Early Development and Radioligand Therapy.Strong knowledge of various agencies guidelines for regulatory filing deliverables and CDISC SDTM and ADaM industry standards. Ability to work and communicate cross-functionally in a global environment to achieve business needs.Represented the department on the leadership teams to propose and finalize departmental computing environment. Also, worked with cross functional teams to implement CDISC strategy in our company.Coordinated and Managed activities of several FDA Advisory committees.Participated and driven multiple navigation meetings with FDA.Specialties: Vendor Management, People Management, Resource Management and Hiring.

Experience

1. Senior Director, Statistical Programming

   Novartis

   Apr 2025 — Present

Education

• Osmania University

  Bachelors

• Boston University

  Masters in Computer Information Systems

Skills

• Software Development Life Cycle (Sdlc)
• 21 Cfr Part 11
• Statistics
• Vendor Management
• Clinical Trials
• Unix
• Databases
• Sas
• CRO Management
• Regulatory Submissions
• Cdisc
• Leadership
• Oracle
• Validation
• Cdisc Standards
• Programming
• Sdlc
• Strategic Planning
• Clinical Research
• Project Planning
• Clinical Development
• Sas Programming
• Pharmaceutical Industry
• Fda
• Regulatory Affairs
• Software Development
• Management
• Data Warehousing
• CRO
• Biotechnology