Description

The Portfolio Lead, Statistical Programming is an experienced functional area project leader with expert knowledge of Statistical Programming strategy, concepts and processes. This position requires strong project leadership skills with the capability to effectively coordinate and oversee Statistical Programming activities across programming teams in accordance with company and departmental processes and procedures.

This position provides matrix leadership to departmental staff and may also provide functional area people leadership to departmental staff in line with business needs.

This position is responsible for formulating the Statistical Programming support strategy across a portfolio of one or more programs, of low to medium complexity, within a Disease Area and/or Therapeutic Area, with accountability for operational oversight and effective planning and execution of statistical programming activities for their assigned portfolio.

Also serving as a statistical programming primary point of contact, this position interfaces with program level Therapeutic Area Leaders to provide regular status updates, identify and manage risks and issues, and ensures the appropriate use of escalation pathways to appropriate functional leaders as needed. As a cross-functional team member, this position ensures effective cross-functional partnership and stakeholder management.

The Portfolio Lead, Statistical Programming also provides leadership and/or expertise in relevant technical areas and/or subject matter in support of process improvement, maintenance and innovation initiatives.

Principal Responsibilities:

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.

Principal Relationships:

• Reports into people manager position within the functional area. Accountable to the Statistical Programming TA Head for assigned programming activities and responsibilities.
• Functional contacts within IDAR include but are not limited to, Statistical Programming TA Head, Programming Leads, peer groups within department, IDAR Therapeutic Area Lead, Data Management, Regulatory Medical Writing, Risk Management Central Monitoring Leads.
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Global Program Leads, Clinical Trial Leads, Quantitative Sciences, Biostatisticians, Regulatory Affairs, Clinical Therapeutic Areas, Global Medical Safety, Bio Research Quality and Compliance, Clinical Project Management Leads, External Alliances, Human Resources, Project Coordinators, Procurement and Finance.
• External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry counterparts and working groups.

Qualifications

• 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.
• Approximately 8-10+ 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.

Preferred Experience

• Experience managing the outsourcing or externalization of statistical programming activities in the clinical trials setting (e.g. Working with CROs, academic institutions).

• Demonstrated people management skills and experience in staff performance management and people development.