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Principal Biostatistician

Job in East Hanover Township, Morris County, New Jersey, 07936, USA
Listing for: Novartis
Full Time position
Listed on 2026-10-13
Job specializations:
  • IT/Tech
    Data Analyst, Information Security & Data Protection, Data Scientist, Data Science Manager
Salary/Wage Range or Industry Benchmark: 119700 - 222300 USD Yearly USD 119700.00 222300.00 YEAR
Job Description & How to Apply Below

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  • Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.

    Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas.

    -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including:

    -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations)
    -Data transfer specifications
    -Analysis data/TFL standards/Define
    -Automation solutions / technologies
    -Business infrastructure, business rules and guidelines.
Summary

  • Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.

    Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas.

    -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including:

    -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations)
    -Data transfer specifications
    -Analysis data/TFL standards/Define
    -Automation solutions / technologies
    -Business infrastructure, business rules and guidelines.
About

The Role

Your

Key Responsibilities:

  • Responsible for all statistical tasks on the assigned trials.
  • Protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities.
  • Contribute to planning and execution of statistical analyses and statistical consultation within your cross-functional teams.
  • Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
  • Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight.
  • Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables.
  • Contribute to external engagement with consultants, advisory boards, health authorities, congresses, and scientific meetings
Video Link

This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely.

Role Requirements

Essential Requirements:

  • PhD with 3+ years’ experience preferred OR MS with 7+ years’ experience
  • Fluent English (oral and written)
  • Strong communication and presentation skills
Novartis Compensation And Benefit Summary

The pay range for this position at commencement of employment is expected to be between: $119,700 and $222,300/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities.

The total compensation…
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