Principal Biostatistician
CD&A GDD
Basel, Switzerland
vor 4 Tg.

Job Description

In this role, you will be responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team.

You will support project level deliverables for a development project with supervision and lead the implementation of modern and innovative clinical trial / experimental designs, statistical models, analyses and data exploration at the study level.

Your responsibilities will include :

  • Study level :
  • a. Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input / review as required.

    Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities.

    Contribute to planning and execution of exploratory analyses, and / or PK, PK / PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation.

    Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.

    b. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.

    c. Contribute to interactions with external review boards / ethics committees, external consultants and other external parties with oversight as appropriate.

    Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.

    d. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the as-signed trials.

    e. Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions / decisions / statements as required.

    f. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.

    g. Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and / or non-clinical related activities.

  • Project level :
  • a. Contribute to project level activities as needed.

    b. Contributes to project team preparation for HA Advisory Committees and meetings.

  • Development Unit or Global Line Function level :
  • a. Contribute to initiatives at global line function level

  • Enterprise level :
  • a. Participate in non-clinical project activities as needed

    b. Contribute to the review and implementation of health authority guidelines

    3. Enterprise level :

    a. Participate in non-clinical project activities as needed.

    b. Contribute to the review and implementation of health authority guidances.

    c. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings.

    5. External level :

    a. Contribute to interactions with external review boards / ethics committees, external consultants and other external parties with oversight as appropriate.

    b. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.

    6. People Management : Mentor new hires and / or junior Statisticians

    Minimum requirements

    What you’ll bring to the role :

  • MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship)
  • Fluent English (oral and written)
  • Good communication and presentation skills
  • Experience in influencing decisions that directly impact the assigned clinical trial and team ability to deliver objectives
  • Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-
  • response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.

    g. SAS, R). Knowledge of drug development and Health Authority guidelines. Ability to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives

  • Experience in Disease / Therapeutic Area and / or regulatory activities desirable
  • WHY CONSIDER NOVARTIS?

    927 million. That’s how many lives our products touched in 2017. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?

    We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

    We are Novartis. Join us and help reimagine medicine.

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