J&J Family of Companies Portfolio Lead Statistical Programmer in San Diego, California
Janssen R&D discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases & vaccines, cardiovascular and metabolic diseases.
Please visit http://www.JanssenRnD.com for more information.
What matters most at J&J is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We thrive on a diverse company culture, celebrating the uniqueness of our employees and a commitment to inclusion. We are proud to be an equal opportunity employer.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for an enthusiastic, innovative, people and project focused Portfolio Lead to join its Statistical Programming and Analysis (SP&A) group within Janssen Research & Development (JRD), located in Spring House, Pa
As a functional area project leader, they play a key role in formulating the Statistical Programming and Analysis strategy across a portfolio of one or more programs of low to medium complexity within a Disease area and/or Therapeutic Area. They provide operational oversight and are accountable for the effective planning and execution of statistical programming activities across multiple clinical trials and cross-trial activities.
This position also provides matrix leadership to departmental staff and may, in line with business needs, provide functional area people leadership.
As a cross-functional team member, they ensure effective cross-functional partnership and stakeholder management and serve as a statistical programming primary point of contact, interfacing with program level Therapeutic Area Leaders to provide regular status updates, identify and manage risks and issues, and ensure the appropriate use of escalation pathways to appropriate functional leaders as needed.
Additionally, they provide leadership or expertise on process improvement and innovation initiatives that shape processes and practices, working proactively to connect with teams, peers and leadership within and cross functions.
As Functional Area Project Leader
Responsible for the planning, execution and completion of all statistical programming activities on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned portfolio.
Accountable for effective resource allocation and utilization in accordance with sourcing decisions, people/partnership development goals and business needs.
Coordinates work allocation of internal and external team members and provides mentorship and guidance to statistical programmers and programming team leaders as needed.
In collaboration with functional leadership, designs statistical programming strategy across assigned portfolio over the life cycle of a compound / program to ensure consistency, efficiency and quality of statistical programming deliverables.
In collaboration with the Statistical lead and other cross functional colleagues, provides input to submission strategy to regulatory agencies and ensures all statistical programming deliverables are complete and compliant, including but not limited to those supporting regulatory agency requests for information and data disclosure.
Contributes to the development and oversight of functional vendor contracts and budget planning for projects within assigned portfolio. Also responsible for effective vendor management and escalation, when appropriate.
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.
Responsible for anticipation, early detection, prevention and management of risks and issues impacting statistical programming deliverables. Effectively manages program level statistical programming issue resolution activities, adopting appropriate escalation pathways as needed.
Responsible for implementation of data and analysis standards, including data life cycle plans, ensuring consistency in analysis dataset design across trials, within a program.
Participates in project or trial initiation activities, as needed.
Collaborates with external partners on statistical programming related activities and deliverables for co-development programs.
Ensures compliance of assigned teams with company and department SOP’s, policies and regulatory guidance documents.
Takes a leadership role for statistical programming related aspects of regulatory agency inspections and J&J internal audits ensuring real time inspection readiness for all statistical programming deliverables.
As a Leader to Support Process Improvements and Innovations
Accountable for actively identifying opportunities, evaluating and driving solutions to enhance efficiency and knowledge-sharing across projects and programs.
Provides input to, and supports strategy for, efficiencies within the TA/value stream.
Contributes to and/or leads departmental innovation and process improvement projects and, as required, may contribute statistical programming expertise to cross functional projects/initiatives.
May contribute to or lead the development of disease or therapeutic area standards and/or lead and develop disease area-specific training.
As Needed, as Functional Area People Leader
Responsible for attracting and retaining top talent, proactively managing performance and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication.
Ensures training compliance and development of appropriate job skills for assigned personnel. Oversees their work allocation, providing coaching and guidance as necessary.
Responsible for local administration and decision making associated with the management of assigned personnel.
Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth) required. Advanced degree (Master’s, PhD or equivalent) preferred.
Experience and Skills:
A minimum of 8 years programming experience with increasing responsibility OR Masters/MBA in a relevant field and 6-8+ yrs relevant experience OR PhD in a relevant field and 5+ yrs relevant experience. Experience in a pharmaceutical/ clinical trial environment preferred.
In-depth knowledge of programming practices and concepts (including tools, languages and processes) and relevant regulatory guidelines (e.g. ICH-GCP) and clinical R&D concepts.
Demonstrated project leadership experience managing and overseeing statistical programming activities, or equivalent where therapeutic/disease area and portfolio knowledge is required.
Demonstrated project leadership experience managing risks, resources and leading teams to successful outcomes.
Experience working on cross-functional teams in a matrix environment with strong communication, influencing and negotiation skills.
United States-Pennsylvania-Spring House-Welsh & McKean Roads
United States-California-San Diego, Belgium-Antwerp-Antwerp, Netherlands-South Holland-Leiden
Janssen Research & Development, LLC (6084)
J&J Family of Companies
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