J&J Family of Companies Scientific Director Quantitative Sciences Consulting in Beerse, Belgium
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 Competencies, 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 (matrix) 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.
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 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.
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.). Actively contributes to external forums/policy shaping/white-papers to shape best practice statistical science. Produces business-relevant publications and presentations. Authors peer-reviewed publications and presentations that are driven by business-related research needs and impact our current practices. Actively participates as a member of professional organizations, such as attending meetings sponsored by professional organizations, serving professional organizations as an officer, event co-coordination, or session chair. Provides editorial services for professional journals. Works with cross pharma consortiums to develop industry standards. Drives 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. Provides input into hiring decisions and ongoing evaluation of talent.
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.
Area Specific Core Competencies, Responsibilities and Accountabilities
Lead and support broad implementation of innovative statistical approaches across the development portfolio. Engage key stakeholders from different key areas, help identifying potential hurdles for broader use of innovation in drug development and finding solutions for them.
Develop and implement innovative approaches, participating in their hands-on implementation through direct interactions with statisticians, clinical teams and other relevant partners. This involves, but is not limited to developing/identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods under a range of scenarios; and participating in the implementation of the selected approaches by engaging in protocol and SAP write-up.
Collaborate with external consultants and qualified CROs to provide support in the development and implementation of innovative methods and designs. Participate in IDMCs for trials with unblinded interim analysis related to innovative approaches (e.g., adaptive designs), as needed.
Identify opportunities for innovation, participate in program reviews/discussions; interact directly with statisticians, TA representatives within SDS, and other QS scientists for early identification of opportunities for innovative approaches.
Help ensure proper knowledge and awareness of innovative methods and designs; help identify, develop, organize, provide and/or arrange training and presentations on innovative approaches across the R&D organization (including statisticians, pharmacometricians, clinicians, and other stakeholder groups) to ensure awareness and adequate knowledge about these methods. Keep up-to-date knowledge of designs and analysis methods for clinical trials, including adaptive designs, model-based methods, etc.
Maintain active external visibility and impact, engage in external collaborations within professional associations (e.g., ASA, IBS, SCT, ISoP, ISCB, PSI, EFPSI)), participating in working groups, program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals. Influence the pharmaceutical industry and regulatory environments, by engaging in scientific advocacy working groups and committees.
Participate in meetings with Health Authorities to discuss innovative designs and analysis methods, as needed.
Sound knowledge of biostatistics applied to clinical trials and model-based drug development.
Experience with planning, running, and documenting simulations (including, but not limited to clinical trial simulations).
Good knowledge of Bayesian methods and inference.
Supervision and Reporting Relationships
This position reports to the Head of QS Consulting and is an individual contributor position with no direct reports.
Matrix supervision may occur up to 5 individuals.
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.
A PhD in Statistics or a related field and 10+ years of experience are required.
Innovative approaches to statistical methodology and/or pharmacometrics and/or clinical pharmacokinetics/pharmacology in Biomedical Research are required.
Basic knowledge of SAS and/or R Programming and software for modeling and simulation, (e.g. ADDPLAN, EAST, FACTS, NONMEM) are required. Leading expert in development and application of Statistical Methodology, Pharmacometrics, and Model-Inform Drug Development and Discovery (MID3) to Pharm R&D is required.
Highly effective written, oral, and interpersonal communication skills.
Role model for individual contributors.
Demonstrated ability to work in interdisciplinary contexts outside statistics.
Europe/Middle East/Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss
Janssen Pharmaceutica N.V. (7555)
Clinical Research non-MD