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 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

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.

Learn more at

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.)

Position Summary:

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.

Principal Responsibilities:

• 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, training as required, may contribute programming expertise to cross functional projects/initiatives.

Clinical Programming:

• Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards.
• Responsible for implementation of data tabulation standards.

Statistical Programming:

• Responsible for the development and implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program.

Principal Relationships:

• The Portfolio Lead reports into a people manager position within the Delivery unit and is accountable to the Director of Programming for assigned activities and responsibilities.
• Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations.
• Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources.
• External contacts include external partners, CRO management and vendor liaisons, industry peers and working groups.

Education and Experience Requirements:

Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD).

Experience and Skills Required:

• Approx. 6+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• In-depth knowledge of programming practices (including tools and processes).
• Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11)
• Project, risk, and team management and an established track record leading teams to successful outcomes.
• Excellent planning and coordination of project delivery.
• Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.
• Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness, adapting to evolving organizations and business environments.
• Experience managing the outsourcing or externalization of programming activities in the clinical trial setting (e.g., working with CROs, academic institutions) is preferred.
• Expert CDISC Standards knowledge.
• Expert knowledge of relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required for a Clinical Programming role.
• Excellent written and verbal communications and influencing and negotiation skills.
• Experience working within the Oncology therapeutic area would be preferred.
• Advanced knowledge of programming and industry standard data structures, thorough understanding of end-to-end clinical trial process and relevant clinical research concepts.

Other:

• Innovative thinking allows for optimal design and execution of programming development strategies.
• Development and implementation of a business change/innovative way of working.
• This position may be located at one of our offices in either Spring House, PA; Raritan, NJ; Titusville, NJ; or La Jolla, CA, and follows a hybrid schedule of three days in the office and two days remotely per week. (No fully remote option available.) May require up to approximately 10% travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is $115,000 to $197.800. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation – up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year

Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.