Johnson & Johnson Careers
Statistical Programming Therapeutic Area Head.
Requisition ID: 1758180910
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 TA Head within the Integrated Data Analytics and Reporting (IDAR) group is responsible for providing input to Stats Programming strategy and deliverables for a therapeutic area, aligned to the overall IDAR and GCDO/RDO strategies. This position is also responsible to collaborate with the peers, Stats Programming and Analysis (SP&A) Head, TA Standards Lead, Chief Standards Officer and IDAR TALs to provide input on process optimization and innovation within the therapeutic area assigned, ensuring alignment across IDAR.
This position supervises Data Analysis Leads, Programming Leads and Statistical Programmers supporting the TA. is accountable to own one or more SP&A processes impacting all TAs.
In addition, this person is accountable for recruiting, resource planning, management and development of all employees within their organization to meet current and future business needs. Coaching and mentoring others as needed.
He/She will provide input to Stats Programming strategy and deliverables, process optimization and innovation across compounds and projects within the therapeutic area assigned.
- As part of the Stats Programming leadership team, contributes to decisions on business strategy, processes, outsourcing and resource allocations across sites. Provides strategic input into the evaluation and reassessment of departmental processes.
- Identifies process optimization and innovation within therapeutic area assigned and ensures alignment of processes and procedures across Stats Programming.
- Provides input to IDAR TALs on study prioritization and resource allocation to ensure programs within therapeutic area assigned are supported. Provides input and approval on resource demand for therapeutic area as part of budget planning in conjunction with Stats Programming peers and Head.
- Makes recommendations around process/policy deviations to adhere or adjust to local or project requirements.
Provides leadership to the Stats Programming team 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, performance management, space allocation, supplies, budget, travel, etc.
- Undertakes people development responsibilities through coaching, 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 Stats Programming Leads and Statistical Programmers from a performance perspective.
- Coordinates with functional Therapeutics Heads and other colleagues to ensure alignment of departmental roles and responsibilities.
Accountable to provide input into the development of departmental policies, procedures, training and standards.
- Policy and standards development and compliance as it relates to the therapeutic area assigned.
- Participates in and/or lead global cross-functional and cross-company initiatives, as applicable.
- Own one or more department procedures, ensuring the processes are up to date and efficient.
- Lead process improvement projects, as needed, to continue building best in class Stats Programming organization.
The successful candidate will establish functional Contacts within IDAR include but are not limited to: Stats Programming Head, Data Managmenet Head, Data Management TA Heads and all other peers in Stats Programming, IDAR TALs, Regulatory Medical Writing, RM-CM (as collaborator or peer).
Functional Contacts Inside the Company (as collaborator and/or peer) include but not limited to: Employees from other departments within Global Clinical Development Operations, eBIS, Quantitative Sciences, BioResearch Quality & Compliance, Project Management Organization, Regulatory Affairs and Operations, Human Resources, Finance, Information Technologies, Janssen R&D Procurement and External Alliances. Cross-sector counterparts in Consumer Devices and Vision Care as necessary.
Therapeutic Area Contacts Inside the Company (as collaborator, IDAR advisor) indirect contact.
Contacts Outside the Company (as collaborator or advisor): Act as J&J representative in Industry counterparts and working groups.
MS/PhD plus 10 years of experience in a leadership function in clinical Stats Programming or biometrics organizations. Excellent people leadership skills and people management experience of 5 to 7 years is strongly preferred. Extensive understanding of Stats Programming, general knowledge of clinical operations and statistical programming practices and systems is needed. The SP&A TA Head requires a knowledge of regulatory guidance documents such as ICH requirements, inter-departmental processes, and relevant Clinical R&D concepts.
In-depth knowledge of project management, team leadership and people development practices.
This position requires knowledge related to talent development and relevant personnel policies and procedures. This position requires knowledge of cross-functional working environment and industry trends that have an effect on departmental resources. This position also requires knowledge of sourcing strategies, resource management, and organizational impact.
United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)