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    Principal Statistician

    Johnson & Johnson
    3+ years
    Not Disclosed
    Remote
    10 Sept. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Principal Statistician

    Function: Data Analytics & Computational Sciences
    Sub Function: Biostatistics
    Category: Principal Scientist, Biostatistics (ST7)
    Location: Greater Mumbai, Maharashtra, India
    Date Posted: September 9, 2024
    Requisition Number: 2406183107W

    Summary:

    As a Principal Statistician at Janssen, you will play a critical role in the design, execution, analysis, and interpretation of data for various stages of clinical development, research, and real-world evidence programs. You will work with minimal supervision to support business-critical and regulatory commitments, contributing to program plans and representing Statistics & Decision Sciences (SDS) across cross-functional and departmental teams. Adhering to Janssen’s Credo and Leadership Imperatives, you will lead, shape, connect, and deliver on key initiatives.

    Core Competencies & Responsibilities:

    • Discovery & Translational:

      • Document projects comprehensively to ensure reproducibility.
      • Serve as the primary consultation contact for new projects and maintain and develop relationships with stakeholders.
      • Manage multiple projects independently from initiation to completion.
      • Provide statistical input for product development and submission-related activities.

    • Statistical Modeling & Methodology:

      • Implement and support innovative statistical approaches across the development portfolio.
      • Develop and apply new methods, including designing simulation studies to evaluate different approaches and contributing to protocol and SAP write-ups.
      • Collaborate with external consultants and participate in professional associations to advance statistical methods and designs.
      • Engage in training and presentations to promote awareness of innovative statistical methods.

    • Manufacturing & Toxicology:

      • Document projects thoroughly and maintain project tracking systems.
      • Oversee statistical aspects of manufacturing and toxicology, ensuring accurate reporting and compliance.

    • Medical Affairs:

      • Provide statistical oversight for Medical Affairs clinical studies, particularly Phase 3b/4 trials and observational studies.
      • Contribute to study design, analysis planning, and development of statistical analysis plans (SAPs) and data presentation plans (DPS).
      • Serve as a statistics representative in cross-functional teams and interact with external investigators and Key Opinion Leaders (KOLs).

    • Real World Evidence (RWE):

      • Identify opportunities for real-world data analysis to support clinical development and feasibility assessments.
      • Act as a liaison between clinical teams and the Epidemiology Analytics Team, translating protocol criteria into data definitions and measuring outcomes.
      • Collaborate with stakeholders to enhance data-driven decision-making through novel technology and RWE analysis.

    Qualifications:

    • Education:

      • Ph.D. in Statistics or a related field with a minimum of 3 years of relevant experience, or a Master’s degree in Statistics or a related field with equivalent experience.

    • Experience:

      • Proficient in SAS or R programming.
      • Excellent written, oral, and interpersonal communication skills.
      • Ability to work independently and in interdisciplinary contexts outside of statistics.
      • Demonstrated experience in applying biostatistics to clinical trials and drug development.

    Skills & Attributes:

    • Strong analytical capabilities and innovative thinking.
    • Proven ability to manage multiple projects and work under tight deadlines.
    • Experience with statistical simulation and Bayesian methods is a plus.

    Application Instructions:

    If you are passionate about advancing statistical science in clinical development and want to make an impact at Janssen, we encourage you to apply. For more details about the role and our organization, please visit our career page.

    Janssen Pharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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