Johnson & Johnson Careers

Director-Early Development Biostatistics

Beerse, Antwerp
Biostatistics


Job Description

Requisition ID: 1805651433W

The Director Early Development Biostatistics contributes to the strategic statistical direction at Janssen through expert-level guidance and input to Early Development, Research & Discovery, Medical Affairs, Real World Evidence, or Manufacturing Sciences programs for research, development, and/or marketed product needs in Janssen.  Manages Direct Reports as a People Leader, and is a leader for strategies, structures, processes, skills, and culture within Statistics & Decision Sciences (SDS). Provides collaborative leadership to other drug development scientists through consultation and mentoring.  Oversees the delivery of analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs. In partnership with other Quantitative Sciences (QS) functions, contributes to strategic long-term decision-making by Janssen Senior Management. Participates in external activities to help shape the external drug research and development and regulatory environments. Serves as a role model for living the Credo and demonstrating the J&J Leadership Imperatives for Leaders: Lead, Shape, Connect, and Deliver. The office location will be Beerse, Belgium.
 
Competencies and Responsibilities:
  • Leadership and Expertise: Is recognized as a leader within Janssen R&D, in particular as a statistical scientific advisor/strategist for a Therapeutic or Functional Area, and for organizational leadership skills.  Has an established track record for strong organizational leadership with the potential for SDS Leadership Team membership.  Gaining recognition as a rising external scientific and/or cross-pharma industry leader. Holds self and others accountable for creating and supporting an environment of trust, collaboration, ethical behavior, diversity, and inclusion. Acts with and leads others to act with a high degree of accountability, agility, and transparency
  • Talent Development: Demonstrates strong skills in leveraging and maximizing the contribution of diverse team members as both single contributors and members of efficient teams. Develops internal talent and attracts external talent through industry and academic connections. Provides leadership support through hiring, developing and retaining team and others. Holds self and people managers accountable for conducting effective performance management and meaningful career development conversations.
  • Quality and Compliance: Serves as a role model for compliance with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidance. Takes responsibility for the compliance of team members and for the quality and timeliness of team deliverables.
  • Resource Management: Supports decision making and aligns priorities to R&D priorities. Demonstrates ability to prioritize/allocate resources against organizational priorities. Assesses and coordinates external statistical support providers
  • Drug Development: Plays a central role in sharing the knowledge and aligning the strategy across all SDS support (Early Development, Research & Discovery, Medical Affairs, Real World Evidence, and Manufacturing Sciences) for a particular Disease/Functional Area. Has an advanced understanding of drug development processes and programs. Has strong experience in regulatory activities (e.g. submissions, interactions).  Demonstrates ability to influence drug research & development strategic plans formulated with Senior Management.  Ensures consistent approaches across compounds and in alignment with regulatory guidance where appropriate. Develops and oversees the development of strategic quantitative frameworks and scenario simulations to evaluate risk tolerance and options in order to optimize program and analysis strategies. Bridges scientific and business needs – integrating quantitative sciences and strong disease or functional area knowledge and appropriate market/competitive intelligence Disease Area Knowledge: Demonstrated knowledge across multiple disease areas/targets within or across Therapeutic Areas (TAs).
  • Innovation: Proactively takes the lead to identify opportunities for innovative solutions to address project critical needs efficiently and effectively. Drives development and implementation of innovative statistical methods and/or drug development strategies
  • Representation: Represents Statistics & Decision Sciences (SDS) on Review Committees (e.g. Development, Document) and provides approval for Regulatory Documents. Interacts with Health Authorities and external key opinion leaders as a J&J statistical expert
  • External Engagement: Identifies critical external scientific/statistical/business trends. Actively contributes to external relationships/industry connections that drive internal outcomes and industry-level guidelines (i.e. enhancing competitive edge, knowledge sharing, talent attraction, corporate reputation advancement, etc.). Supports and enables others to establish similar relationships and connections. Actively contributes to external forums/policy shaping/white-papers to shape best practice statistical science.  Actively participates as a member of professional organizations, such as attending meetings sponsored by professional organizations, serving professional organizations as an officer, or event co-coordination, or session chair. Works with cross pharma consortiums to develop industry standards. Contributes to the advancement of statistical methodology through publications. Peer reviews or edits professional journal manuscripts.
  • Mentor: Serves as a role model, and mentor to statisticians and other scientists. Takes a lead role in sharing statistical knowledge, within SDS and/or cross-functionally. Mentors junior colleagues in techniques, processes, and responsibilities.
  • Process: Identifies, leads, and implements process improvements. Develops training and standards. Demonstrates adaptability to change and serves as a role model to drive departmental alignment with strategic changes.
  • Complexity: Demonstrated performance in progressive, advanced, complex programs/studies
  • Collaboration: Demonstrates strong skills in negotiating agreements and building internal cross-functional partnerships and external relationships that improve communication, efficiency, and productivity. Collaborates effectively with SDS colleagues and with external sourced partners to achieve results for project specific needs. Works across a matrix organization and cross-functionally to identify and resolve issues. Leverages SDS role in drug research and development to help support broader R&D Operations (RDO) objectives.
  • Communication: Demonstrates excellent written, oral, and interpersonal communication skills.  Demonstrated ability to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners and positively influencing their decisions.
  • Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required. 
     
Supervision and Reporting Relationships:
This position reports to a Senior Director or above.
Responsibility for managing teams of approximately 5 direct J&J internal reports (or supervision of equivalent  internal and external resources per portfolio demands and sourcing strategies).
 
Interfaces:
Internal: Statistics & Decision Sciences, Clinical Pharmacology & Pharmacometrics, Clinical Teams (or Equivalent) and associated working groups, Statistical Programming, Medical Writing, heads and leaders and scientists within Therapeutic and Functional Areas, R&D Operations, Medical Affairs, Manufacturing, Safety, Epidemiology, Regulatory Affairs, Marketing, Quality, Human Resources, Information Technology, Finance, Project Management Office.
External: Contracted Partners and Suppliers, Regulatory Authorities, Governmental Bodies, Key Opinion Leaders, Academia, Professional Societies, Advisory Boards, Trial committees, External statistical experts, Public/Private Consortia.

Qualifications
  • Ph.D. in Statistics or related field with minimum 9 years relevant experience, or
  • Master’s in Statistics or related field with commensurate years of relevant experience.
  • Proficient in SAS or R programming.
  • Highly effective written, oral, and interpersonal communication skills.
  • Demonstrated people leadership and management skills.
  • Demonstrated ability to work in interdisciplinary contexts outside statistics.

Primary Location
Belgium-Antwerp-Beerse
Other Locations
Europe/Middle East/Africa-Netherlands
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Biostatistics
Requisition ID
1805651433W