J&J Family of Companies Director, Modeling & Decision Sciences in San Diego, California
Janssen Research & Development part of the Johnson & Johnson Family of Companies is recruiting for a Director, Modeling & Decision Sciences located in San Diego, CA.
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. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.
The Director will be responsible for:
Supporting the identification of opportunities and implementation of strategies to utilize innovative methods that improve quantitative decision making at program and portfolio levels, including development and application of model-based meta-analysis (MBMA)
Proposing and developing innovative designs and analysis methods to integrate external data and evaluating them via simulation studies and other appropriate instruments
Interacting with clinical teams to ensure the proper application of these innovative approaches
Supporting internal training on innovative methods (e.g., MBMA) to ensure adequate knowledge and awareness across the company
Participating in external collaborations and interactions (via professional associations, conferences, publications, etc.) to influence the external pharmaceutical industry and regulatory environment.
Support the integration of external data sources (primarily external aggregate clinical trial [ExACT] data) into drug development decision-making processes
Support implementation of strategy to ensure broader utilization of innovative approaches across the development portfolio, using internal and external data sources, through coordinated efforts involving clinical, operational, regulatory areas, with a focus on methods and approaches to improve decision making at a portfolio level (e.g., MBMA, Bayesian Decision Analysis, Probability of Success, expected Net Present Value estimation, etc.)
Help bring together key stakeholders from different key areas and identify potential hurdles for broader use of innovation in drug development and participate in finding solutions for them
Support development and implementation of innovative approaches: participate in hands-on implementation, through direct interactions with clinical teams and other relevant groups. This involves helping develop and identify appropriate designs and methods; planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods; and participating in the implementation of the selected approaches by engaging in protocol and SAP write-up.
Support identification of opportunities for innovation: participate in compound development team reviews/discussions, interact directly with clinical teams for early identification of opportunities.
Ensure proper knowledge and awareness of methods to integrate external data into decision making: support identification, development, organization and deployment of training and presentations on innovative approaches across the Development organization (including statisticians, modelers, clinicians, and other stakeholder groups). Keep up-to-date knowledge of designs and analysis methods for clinical trials, including MBMA, adaptive designs, model-based methods, etc.
External collaborations, visibility, and impact: engage in external collaborations within professional associations (e.g., ISoP, ASA, PhRMA), organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals.
Carry out functional responsibilities in accordance with applicable SOPs/Guidelines and Regulatory requirements
Assists in process improvement initiatives and SOP/Guideline development
A Doctorate (Ph.D.) or equivalent in Engineering, Statistics, Pharmacometrics, Data Science, or related field, with a minimum of eight (8) years relevant work experience in pharmaceutical development OR a Master’s degree in related field with a minimum of twelve (12) years of relevant work experience.
Experience and Skills:
Working knowledge of statistical modeling software, such as R
Deep understanding of statistics and probability
Fluent in written and spoken English
Ability to build and maintain effective working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships)
Ability to multi-task and prioritize assignments, establishing course of action to ensure that work is completed efficiently and in a timely manner (planning, organizing and time management)
Actively identifying new areas for learning, and application to the job (continuous learning)
Good sense of cultural sensitivity and diversity (cultural diversity)
Self-motivated with the ability to work independently with minimal supervision (personal accountability)
Ability to interface with people of various groups (e.g., biostatistics, clinical pharmacology, clinical, etc.) and disciplines
Ability to thrive in a global, matrix environment
Sound knowledge of biostatistics applied to clinical trials and model-based drug development
Deep understanding of probabilistic concepts accompanied by familiarity with decision strategy
Experience with trial simulations to design and document adaptive trials and working knowledge of Bayesian methods.
Stay current with the latest statistical methodologies with focus on trial optimization, simulation and adaptive designs.
Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical drug development, including the conduct of clinical trials
Excellent verbal and written communication skills, including formal presentation skills. Experience presenting to technical and lay groups at public meetings desirable. Written skills as evidenced by publication and journal articles also desirable.
This position may require up to 10% domestic and international travel.
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 States-California-San Diego-3210 Merryfield Row
Janssen Research & Development, LLC (6084)