Associate Director, Operations Functional Lead (Statistical Programming)
Location:
Raritan , New Jersey
Posted:
February 06, 2017
Reference:
9663161103-en-us

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 required.

 

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 (statistical programming).

 

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 needed.

 
Responsibilities:
  • The 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.
  • Actively participate or lead Community of Practice, operational strategy and process recommendations
  • Provides supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc.
  • Provides strategic input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model.
  • Ensures compliance with department SOPs, policies and regulatory guidance documents.
  • Coordinates with other OFLs, Value Stream Leads and colleagues to ensure alignment of departmental roles and responsibilities.
  • Fulfils 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.
  • Leads 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.
  • Provides leadership in establishing operational  strategy and process recommendations.
  • Ensures quality and compliance is  monitored for deliverables, may provide input into the establishment of metrics
  • Takes a leadership role in process improvement initiatives as appropriate
  • Fulfils 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


Qualifications
  • Bachelors’ Degree and 8+ years relevant experience OR Masters/MBA and 6+ years relevant experience OR PhD with 4+ years relevant experience is required.
  • People management experience is required. 
  • 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 required
  • 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
#HEMAONCO
Primary Location
United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Biostatistics

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