At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
The Scientific Director contributes to the strategic statistical direction at Janssen through expert-level guidance and input to Pre/Early/Late Development, Research & Discovery, Medical Affairs, Real World Evidence, or Manufacturing Sciences programs for research, development, and/or marketed product needs in Janssen. 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 Individuals: Lead, Shape, Connect, and Deliver.
Position Core Proficiencies, Responsibilities and Accountabilities
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/or an analytics expert across Statistics. Gaining recognition as a rising, external scientific and/or cross-pharma industry leader. Acts with a high degree of accountability, agility, and transparency. May provide functional supervision as a statistical project lead.
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 quality and timeliness of deliverables.
Drug Development: Plays a central role in sharing the knowledge and aligning the strategy across all Statistics & Decision Sciences (SDS) support (Pre/Early/Late Development, Research & Discovery, Medical Affairs, Real World Evidence, and Manufacturing Sciences) for technical/scientific aspects of 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 as appropriate. Takes an expert level lead in developing and applying 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.
Innovation: Actively takes the lead to find opportunities for innovative solutions to address project critical needs efficiently and effectively. Drives the development and implementation of innovative statistical methods and/or drug development strategies.
Representation: Represents Statistics & Decision Sciences 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. May serve as the SDS representative for Due Diligence activities.
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. You are flexible to change and driving departmental alignment with strategic changes. Provides input into hiring decisions and ongoing evaluation of talent.
Complexity: Demonstrated performance in progressive, advanced, complex programs/studies.
Collaboration: You are a skilled 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. You are able to collaborate and consult with non-statisticians, translating complex statistical concepts to drug research & development partners and positively influencing their decisions.
Do you have the Education and Experience Required for this role?
- Ph.D. or MSc in Statistics /related field experience!
- Statistics experience in Pharma industry
- Proficient in SAS or R programming!
- Role model for individual contributors.
- Demonstrated ability to work in interdisciplinary contexts outside statistics.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)