Senior I Clinical Programming Lead

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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 :

Principal Relationships :

This role reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities.

Education and Experience Requirements :

Bachelor's degree or higher and / or equivalent in computer science, mathematics, data science / analytics / data engineering, public health, or other relevant scientific field (or equivalent theoretical / technical depth).

Experience and Skills Required :

Required Skills : Preferred Skills :

Advanced Analytics, Biostatistics, Clinical Trials, Collaborating, Consulting, Critical Thinking, Data Privacy Standards, Data Quality, Data Savvy, Digital Fluency, Good Clinical Practice (GCP), Quality Assurance (QA), Report Writing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Statistics, Systems Development, Technologically Savvy]]>