Portfolio Lead, Statistical Programming at Johnson & Johnson in Spring House, PA
The Portfolio Lead, Statistical Programming will provide 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 individual will provide matrix leadership to departmental staff and may also provide functional area people leadership to departmental staff in line with business needs. Formulate 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. As a cross-functional team member, the Portfolio Lead will ensure effective cross-functional partnership and stakeholder management. 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. Provide leadership and/or expertise in relevant technical areas and/or subject matter in support of process improvement, maintenance and innovation initiatives. Principal
Responsibilities:
Functional Area Project Leader:
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. Coordinate 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, design 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, provide 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. Contribute to the development and oversight of functional vendor contracts and budget planning for projects within assigned portfolio. Effective vendor management and escalation, when appropriate. Proactively evaluate and manage 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. 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. Implementation of data and analysis standards, including data life cycle plans, ensuring consistency in analysis dataset design across trials, within a program. Participate in project or trial initiation activities, as needed. Collaborates with external partners on statistical programming related activities and deliverables for co-development programs. Ensure compliance of assigned teams with company and department Standard Operating Procedures (SOPs), policies and regulatory guidance documents. Take a leadership role for statistical programming related aspects of regulatory agency inspections and Johnson & Johnson 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. Provide input to, and supports strategy for, efficiencies within the TA/value stream. Contribute 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 Functional Area People Leader (as needed):
Attracting and retaining top talent, proactively managing performance and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication. Ensure training compliance and development of appropriate job skills for assigned personnel. Oversee their work allocation, providing coaching and guidance as necessary. Local administration and decision making associated with the management of assigned personnel. Qualifications A minimum of a Bachelor's degree in Computer Science, Mathematics, Data Science/Analytics, Public Health or a related discipline is required. Advanced degree (Master's, PhD) preferred. A minimum of 8 years of relevant industry experience with a Bachelor's degree; a minimum of 6 years of relevant industry experience with a Master's degree; or a minimum of 4 years of relevant industry experience with a PhD is required. Experience in a pharmaceutical/clinical trial operations environment preferred. In-depth knowledge of programming practices and concepts (including tools, languages and processes) is required. Knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and clinical R&D concepts is required. Demonstrated project leadership experience managing and overseeing statistical programming activities is required. Demonstrated project leadership experience managing risks, resources and leading teams to successful outcomes required. Experience managing the outsourcing or externalization of statistical programming activities in a clinical trial setting (e.g. working with Contract Research Organizations (CROs), academic institutions) is preferred. Demonstrated people management skills and experience in staff performance management and people development is preferred. Must have excellent communication skills. Must have strong influencing and negotiation skills. The ability to collaborate with cross-functional teams in a matrix environment is required.
Salary Range:
$100K -- $150K
Minimum Qualification
Program ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Functional Area Project Leader:
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. Coordinate 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, design 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, provide 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. Contribute to the development and oversight of functional vendor contracts and budget planning for projects within assigned portfolio. Effective vendor management and escalation, when appropriate. Proactively evaluate and manage 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. 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. Implementation of data and analysis standards, including data life cycle plans, ensuring consistency in analysis dataset design across trials, within a program. Participate in project or trial initiation activities, as needed. Collaborates with external partners on statistical programming related activities and deliverables for co-development programs. Ensure compliance of assigned teams with company and department Standard Operating Procedures (SOPs), policies and regulatory guidance documents. Take a leadership role for statistical programming related aspects of regulatory agency inspections and Johnson & Johnson 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. Provide input to, and supports strategy for, efficiencies within the TA/value stream. Contribute 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 Functional Area People Leader (as needed):
Attracting and retaining top talent, proactively managing performance and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication. Ensure training compliance and development of appropriate job skills for assigned personnel. Oversee their work allocation, providing coaching and guidance as necessary. Local administration and decision making associated with the management of assigned personnel. Qualifications A minimum of a Bachelor's degree in Computer Science, Mathematics, Data Science/Analytics, Public Health or a related discipline is required. Advanced degree (Master's, PhD) preferred. A minimum of 8 years of relevant industry experience with a Bachelor's degree; a minimum of 6 years of relevant industry experience with a Master's degree; or a minimum of 4 years of relevant industry experience with a PhD is required. Experience in a pharmaceutical/clinical trial operations environment preferred. In-depth knowledge of programming practices and concepts (including tools, languages and processes) is required. Knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and clinical R&D concepts is required. Demonstrated project leadership experience managing and overseeing statistical programming activities is required. Demonstrated project leadership experience managing risks, resources and leading teams to successful outcomes required. Experience managing the outsourcing or externalization of statistical programming activities in a clinical trial setting (e.g. working with Contract Research Organizations (CROs), academic institutions) is preferred. Demonstrated people management skills and experience in staff performance management and people development is preferred. Must have excellent communication skills. Must have strong influencing and negotiation skills. The ability to collaborate with cross-functional teams in a matrix environment is required.
Salary Range:
$100K -- $150K
Minimum Qualification
Program ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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