Principal Portfolio Lead, Statistical Programming - Oncology
Company: Johnson & Johnson
Location: Spring House
Posted on: July 4, 2025
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Job Description:
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: 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
https://www.jnj.com/innovative-medicine 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
(ra-employeehealthsup@its.jnj.com) 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.
https://www.careers.jnj.com/employee-benefits 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.
Keywords: Johnson & Johnson, Lower Merion , Principal Portfolio Lead, Statistical Programming - Oncology, Science, Research & Development , Spring House, Pennsylvania
