Johnson & Johnson Careers
Senior Manager Statistical Programming Leader
Leiden, Netherlands; Beerse, Belgium
Requisition ID: 1805692356W
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 hiring, onboarding, performance management, budget, travel, etc.
Undertakes performance development responsibilities through coaching, functional and disease area training , and performance management as well as ensure compliance with department SOP’s, policies and regulatory guidance documents.
Accountable for the decisions made by the programmers from a performance perspective.
This position is accountable for recruiting, resource planning, management and development of all employees within their area of responsibility to meet current and future business needs. Coaching and mentoring others as needed.
Contributes to or leads the development and maintenance of departmental policies, procedures, training and standards.
Accountable for actively identifying opportunities, evaluates and drives solutions to enhance efficiency and knowledge-sharing at the department level. Stays current with industry trends that have an effect on departmental processes.
Serves as departmental resource in areas of technical expertise.
May participate in cross-IDAR or cross-functional initiatives/process improvements.
Principal Relationships: Functional contacts within IDAR include but are not limited to, TA Head, IDAR TAL, Programmers, Data Management Leads, Regulatory Medical Writing Leads, Risk Management Central Monitoring Leads.
Functional contacts Janssen (as collaborator or peer) include but are not limited to GCDO Global Program Leads, GCDO Global Trial Leads, Quantitative Sciences, Biostatisticians, Regulatory, Clinical, 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
Bachelors degree and 6+ yrs relevant experience OR Masters/MBA and 4+ yrs; OR PhD with post-doc experience with 3+ yrs. University/college degree in a scientific discipline is preferred.
In-depth knowledge of programming practices (including tools and processes) and relevant regulatory guidelines is required. TA experience and strong portfolio knowledge is required. Project management experience dealing with customers, leading teams to successful outcomes, outsourcing strategies, contract oversight, negotiations and leading through influence are recommended . Experience working on cross-functional teams is required. Experience supervising staff is preferred.
Demonstrated strong communication skills and experience working within a matrix environment. Excellent leadership, decision-making skills and proven ability to foster team productivity and cohesiveness, act as a change agent, and adapt to rapidly changing organization and business environment. Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies.
In depth knowledge of regulatory guidance documents such as GCP / ICH requirements and relevant clinical R&D concepts.
Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Janssen Biologics (7266)