Janssen Research & Development, L.L.C., a member of Johnson
& Johnson's Family of Companies, is recruiting for Associate Director, Operations
Functional Lead (Statistical Programming) located in
Raritan NJ. Up to 10% travel is
Janssen Research & Development, L.L.C. develops treatments
that improve the health and lifestyles of people worldwide. Research and
development areas encompass novel targets in neurologic disorders,
gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic
disorders, immunologic disorders, and reproductive medicine.
The Associate Director, Operations Functional Lead (OFL) within
Integrated Data Analytics and Reporting group is responsible for the personnel
development and performance management activities for approximately 9-15 direct
reports, supporting the late development Oncology portfolio This is a management level position where
problem solving and decision-making are expected and required.
The OFL will take on additional roles such as Business Owner for
one or more departmental processes or as a single point of contact (SPOC) role
for an external sourcing provider. The OFL provides significant leadership in
the development of department policies, process, training and/or standards. The
OFL will actively participate or lead a Community of Practice in order to align
cross functionally within Data Delivery (data management) and Data Analysis
This position makes decisions and recommendations that will have a
direct impact on the project delivery, resource allocation, and success of the Late
Development Oncology Statistical Programming team. Decisions that are made by
this position will also impact IDAR cross-functionally.
The OFL will effectively co-ordinate and manage SAS Statistical
Programmers and is accountable for recruiting, resource planning, management
and development of all employees to meet current and future business
needs. Coaching and mentoring others as
individual is responsible for the performance management, development salary
administration for direct reports, staff recruitment and will make decisions
appropriate to this type of oversight and management.
participate or lead Community of Practice, operational strategy and process
supervisory support to direct reports, including coaching, mentoring, training,
career development, priority setting, etc.
strategic input into departmental staffing and/or sourcing strategy and ongoing
evaluation of staffing/sourcing model.
compliance with department SOPs, policies and regulatory guidance documents.
with other OFLs, Value Stream Leads and colleagues to ensure alignment of
departmental roles and responsibilities.
role of business owner for one or more processes of medium/high complexity
and/or significant departmental or cross-functional impact. The individual is responsible for seeking
input and making strategic decisions regarding the development, execution, and
maintenance of the process in collaboration with the Value Stream Leads of
early development, late development and medical affairs.
departmental projects and implements solutions in collaboration with
others. Identifies areas of opportunity,
evaluates and gives input on solutions to enhance efficiency and
knowledge-sharing within Data Delivery and Analysis (DDA) and IDAR.
leadership in establishing operational
strategy and process recommendations.
quality and compliance is monitored for
deliverables, may provide input into the establishment of metrics
a leadership role in process improvement initiatives as appropriate
the role of a SPOC for one or more external sourcing providers being responsible
for establishing a strategic partnership, ensuring adherence to contract
agreements, following up on capacity management, deliverables and compliance in
close collaboration with other IDAR partners and procurement
- Bachelors’ Degree and 8+ years relevant experience OR Masters/MBA
and 6+ years relevant experience OR PhD with 4+ years relevant experience is
- People management experience is
- In-depth knowledge of SAS statistical programming practices and
systems in a clinical research setting is required.
- Experience supporting clinical trials in the Oncology therapeutic
area is preferred.
- Knowledge of regulatory guidance documents such as ICH
requirements, inter-departmental processes, and relevant Clinical R&D
concepts are required.
- In-depth knowledge of project management and leading teams is
- Knowledge related to talent development and relevant personnel
policies and procedures is preferred
- Knowledge of cross-functional working environment and industry
trends that have an effect on departmental resources is required
- Knowledge of sourcing strategies, resource management, and
organizational impact is required
United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function