Senior I Clinical Programming Lead

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Data Analytics & Computational Sciences

Job Sub Function:
Biostatistics

Job Category:
Scientific/Technology

All Job Posting Locations:
Mumbai, India

Job Description:

Principal Responsibilities:
• Responsible for planning, programming strategy, coordination, oversight, and execution of team activities following J&J IM and industry standards for one or more clinical trials or projects.
• Designs and develops programs in support of complex clinical data analysis and reporting activities.
• Supports submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages and reviewer’s guides.
• Provides technical and project-specific guidance to team members, ensuring high-quality, efficiency and on-time deliverables in compliance with departmental processes and procedures.

Ensures use of latest standards and deployment of current technologies.
• Collaborates effectively with cross-functional team, counterparts, vendors to achieve project goals and manages escalations independently.
• Supports submission activities while ensuring the highest level of consistency and quality across trials by creating efficiencies in clinical data flow and implementing metadata-driven approaches.
• As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.
• May play the role of a Delivery Unit/Disease Area Expert contributing to standards strategy and providing expertise for a specific Delivery Unit/Disease area across value streams in support of clinical programs including submissions.

Contributes to departmental innovation and process improvement projects by supporting and/or leading developing and implementing processes, systems, and tool improvement initiatives.
Clinical Programming:
• Ensures the utilization of latest standards and technologies, adhering to regulatory requirements, and creating effective mapping algorithms and Data Review Model (DRM) and designs mapping algorithms for non-standard conversions as needed.
• Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring.

Principal Relationships:
This role reports into a...