Principal Portfolio Lead Statistical Programming Oncology

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 Med Tech, 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.

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Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for a Principal Portfolio Lead, Statistical Programming - Oncology
, to be located at one of our offices in either Spring House, PA;
Raritan, NJ;
Titusville, NJ; or La Jolla, CA. (No remote option.)

This role is a highly experienced project leader with expert understanding of programming strategies, practices, methods, processes, technologies, industry standards and complex data structures, analysis, and reporting solutions.

This position is responsible for formulating the programming strategy across a portfolio of one or more programs, compounds, indications, disease areas within a delivery unit, with accountability for operational oversight and effective planning and execution of programming activities for their assigned portfolio while ensuring effective partnership with and management of stakeholders.

The role directly contributes to delivery of the J&J IM R&D portfolio through effective leadership and accountability while making autonomous decisions and recommendations that impact efficiency, timeliness, and quality of programming deliverables on large or complex clinical development programs and provides technical and project specific guidance to programming teams.

The Portfolio Lead in Clinical & Statistical Programming (C&SP) also provides leadership and expertise in relevant technical areas and subject matter in support of process improvement, maintenance, and innovation initiatives and develops strong and productive working relationships with key stakeholders within IDAR in addition to broader partners, external suppliers, and industry groups.

This position provides matrix leadership to departmental staff.

• Responsible for the end-to-end planning, execution, and completion of all programming activities within a portfolio, compound, disease area, indication in a Delivery Unit on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned area.
• Provides mentorship and guidance to programmers and programming team leads as needed.
• Responsible for anticipation, early detection, prevention and management of risks and issues impacting programming deliverables. Effectively manages program level programming issue resolution activities, adopting appropriate escalation pathways as needed.
• Accountable for actively identifying opportunities, evaluating, and driving solutions to enhance efficiency and knowledge-sharing across projects and programs.
• Designs programming strategy across assigned portfolio over the life cycle of a compound/ program to ensure consistency, efficiency, and quality of programming deliverables.
• Proactively evaluates and manages resource demand and allocation to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems. This includes forecasting related to potential in-licensing and acquisitions.
• Contributes to the development and oversight of functional vendor contracts and budget planning for projects within assigned portfolio including effective vendor management and escalation. As applicable, oversees activities outsourced to vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality.
• Leads programming related aspects of regulatory agency inspections and J&J internal audits ensuring real time inspection readiness for all programming deliverables.
• Provides input to submission strategy to regulatory agencies and ensures all programming deliverables are complete and compliant.
• Contributes to and/or leads departmental innovation and process improvement projects and development of disease or therapeutic area standards,…