- Entry level
- No Education
- Salary to negotiate
The Statistical Programming Leader (SPL) – Senior Manager within the Integrated Data Analytics and Reporting (IDAR) plays the roles of both project and people leader within the Statistical Programming and Analysis functional area.
As functional area project leader is responsible for formulating the Statistical Programming and Analysis strategy of one or more programs of low to medium complexity within a disease area and/or therapeutic area. The SPL provides operational oversight and is accountable for the planning and execution of statistical programming activities across multiple clinical trials and cross-trial activities for the programs assigned.
As functional area people leader, the Senior Manager level SPL manages others and is responsible for recruitment, onboarding, performance management and people development as applicable. In this role, the SPL is also accountable for effective resource allocation and utilization of resources as well as optimal assignment of work in accordance with sourcing decisions, people/partnership development goals and business needs.
This position serves as the statistical programming primary point of contact for the GCDO Program Leader (GPL) and is accountable to the GPL for statistical programming deliverables at the program level in collaboration with other functional area members. This position interfaces with program level Therapeutic Area (TA) leaders to provide regular trial and/or program status updates and leads proactive problem solving as well as escalation of statistical programming issues to appropriate functional leaders as well as cross-functional leaders as needed.
Additionally, the Senior Manager level SPL provides leadership and expertise in relevant technical areas and process/standards projects/initiatives. Is expected to show initiative in connecting with functional /cross-functional members in sharing lessons-learned and shaping processes and practices in line with Statistical Programming and Analysis strategic vision
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 programs.
In collaboration with management, designs statistical programming strategy across multiple studies within a program and for non-trial activities over the life cycle of a compound / program to ensure consistency, efficiency and proactive problem solving solutions for statistical programming deliverables.
In collaboration with the Statistical lead and other cross functional colleagues, provides input for submission strategy to regulatory agencies and ensures all statistical programming related submission deliverables are complete and compliant.
Responsible for implementation of data life cycle plans and ensuring consistency in analysis dataset design across trials, within a program.
Serves as the statistical programming primary point of contact to the GCDO GPL for trial-related activities and CPL for a given program. Represents Statistical Programming and Analysis on the clinical team for cross-trial activities as needed.
Contributes to the development of Statistical Programming and Analysis vendor contracts and R&D Company business planning budget estimates. Oversees vendor management and escalation for projects within their programs.
Proactively evaluates resource demand and ensures updates to functional planning systems.
Responsible for anticipation, prevention and early detection of issues impacting statistical programming deliverables for a program. Manages program level statistical programming issue resolution activities and escalates as needed
Participates in project or trial initiation activities, as needed.
Collaborates with external partners on statistical programming related deliverables for co-development programs.
Takes a leadership role for statistical programming related aspects of regulatory agency inspections and J&J internal audits. Coordinates real time inspection readiness for all statistical programming deliverables as necessary.
Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
Charged with making decisions associated with the management of assigned personnel and local administration, including
About the company
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