Johnson & Johnson Careers

Statistical Programming Lead–Associate Director

Raritan, New Jersey
Biostatistics


Job Description

Requisition ID: 1003180509

Janssen Research & Development, L.L.C, a member of the Johnson & Johnson Family of Companies, is recruiting for a Statistical Programming Lead–Associate Director located in Spring House, PA, Raritan NJ or Titusville, NJ with up to 15% travel. 
 
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information. 

The Statistical Programming Lead (SPL) – Associate Director 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.

Responsible for formulating the Statistical Programming and Analysis strategy for the Medical Affairs Oncology portfolio of medium to high complexity within Oncology 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, Statistical Programming Lead (SPL) – Associate Director 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 Medical Affairs Clinical Program Leader (CPL) and is accountable to the CPL, and the team 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 Statistical Programming Lead (SPL) – Associate Director provides leadership and expertise in relevant technical areas and process/standards projects/initiatives with minimum guidance. Is expected to show initiative in connecting with functional/cross-functional members in sharing lessons-learned and shaping processes and practices in line with SPL’s strategic vision.

RESPONSIBILITIES: 

• 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 Medical Affairs oncology strategy and ensures all statistical programming related 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 CPL for trial-related activities for a given program. Represents Statistical Programming and Analysis on the clinical team for cross-trial activities as needed.
• Contributes to the development of vendor contracts and Medical Affairs Operating 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. Manages Medical Affairs Oncology 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.
• 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.
• Provide significant input and/or leadership into 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 influence departmental processes.
• Serves as departmental resource in areas of technical expertise.


Qualifications
• A Bachelor’s degree, preferable within a scientific discipline with 8 years relevant experience OR Masters/MBA with 6 years relevant experience; OR PhD with post-doc experience and 4 years relevant experience is required.
• In-depth knowledge of programming practices (including tools and processes) and relevant regulatory guidelines is required.
• Medical Affairs Oncology 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 required.
• Experience working on cross-functional teams is required.
• Experience supervising staff is required.
• Experience with non-interventional and real-world evidence projects is preferred.
• Demonstrated strong communication skills and experience working within a matrix environment is required.
• 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 is required.
• Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies is preferred.
• In depth knowledge of regulatory guidance documents such as GCP/ICH requirements and relevant clinical R&D concepts is strongly preferred.


Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Biostatistics
Requisition ID
1003180509