Principal Statistician - Neurology
Johnson & Johnson
Prague, Czech Republic
před 3 dny

Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for a Principal Statistician, located in High Wycombe, United Kingdom.

The Principal Statistician supports the design, execution, analysis, interpretation, and reporting or communication of data evidence for Pre / Early / Late Clinical Development, Research & Discovery, Medical Affairs, programs for research, development, and / or marketed product needs in Janssen, with minimal direction.

Statistical Modelling & Methodology

  • Support broad implementation of creative statistical approaches across the development portfolio.
  • Support development and implementation of innovative ways, participating in their hands-on implementation through direct interactions with statisticians.
  • This involves, but is not limited to, identifying appropriate designs and methods, decision rules (e.g., Go / No Go); planning, running, and summarising 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 to provide support in the development and implementation of innovative methods and designs.
  • Find opportunities for innovation; directly contact with statisticians and other QS scientists for early identification of opportunities for innovative ways.
  • Participate in training and presentations on innovative approaches across the R&D organisation (including statisticians, pharmacometricians, clinicians, and other partner 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.

  • May 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.
  • Having knowledge of biostatistics applied to clinical trials and model-based drug development.
  • Experience in planning, running, and documenting simulations (including, but not limited to clinical trial simulations).
  • having an awareness of Bayesian methods and inference.
  • Key Responsibilities :

  • Support statistical aspects of business-critical and / or regulatory commitments,
  • Provide input to program plans with limited supervision
  • Represent Statistics & Decision Sciences (SDS) for cross-functional and intra-departmental teams or working groups.
  • Abide by the Credo and practices J&J Leadership Imperatives for Individuals : Lead, Shape, Connect, and Deliver.
  • Qualifications

    Do you meet the required Qualification requirements below?

  • Demonstrates sophisticated data analytic expertise based on a foundation of statistical principles and a strong track record of applied experience leading to successful program support!
  • Is effective in the use of tools for study, experiment, or trial research objectives.
  • Applies high quality statistical methodology in assigned projects with proven understanding of the disease / scientific / functional area and health authority acceptability.
  • Takes the lead in providing SDS support to experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications.
  • Is accountable for execution of individual project responsibilities, including : meetings with necessary project team members, reporting activities, exploratory analyses / graphics, and additional analyses
  • Has very good written, oral, and interpersonal communication skills. Demonstrated ability to collaborate and advise non-statisticians, translating sophisticated statistical concepts to drug research & development partners!
  • Demonstrates full proficiency in SAS and / or R, as well as a solid understanding of other relevant computational tools as required.
  • Ph.D. or Masters in Statistics or related field
  • Experience within the Neurology therapeutic area
  • We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

    Please contact us to request accommodation.

    Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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