Director Quantitative Safety Scientist - Advanced Accelerator Applications
  • Dublin, Leinster, Ireland
  • via BeBee.com
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Job Description

As a Director Quantitative Safety Statistician at Novartis, you will shape the quantitative safety strategy for multiple programs across multiple indications during the whole life cycle.

**Job Summary:** Develop and implement innovative quantitative safety science strategies to inform internal and external evidence-based decision-making, ensuring patients receive more benefits than risks.

**Key Responsibilities:**

  • Establish quantitative safety science strategy for assigned programs, including early and full development, pre-, peri- and post-regulatory submissions.
  • Contribute to strategy design, analysis, interpretation, and reporting for complex studies across programs/indications.
  • Lead collaborations with medical safety, epidemiology, clinical, regulatory, and other quantitative scientists to ensure data-driven decision-making.
  • Propose and implement modern statistical methods to support safety signal detection, risk assessment, and benefit-risk evaluation.
  • Promote the use and acceptance of these methods within and outside the organization through presentations, publications, and scientific collaborations.
  • Identify and lead cross-functional scientific improvement initiatives, providing strategic, technical, operational, and scientific solutions.
  • Represent Quantitative Safety & Epidemiology at internal and external decision boards.
  • Mentor others in developing strategic quantitative frameworks.

**Requirements:**

  • University degree in statistics or mathematics or related area (PhD preferred).
  • 10+ years (or 8+ years for PhD) of relevant experience in positions with growing responsibility in the Pharmaceutical Industry.
  • Expert knowledge and experience of statistical methods applied to drug development and post-marketing safety and benefit-risk assessments.
  • Hands-on experience in interactions with regulatory agencies.
  • Demonstrated experience in developing and evaluating modern quantitative safety methodologies.
  • Computing ability and experience with different data sources.
  • Scientific curiosity combined with strong communication skills bridging scientific and business needs.
  • Proven successful experience in leading global scientific improvement/change initiatives.
  • Natural modern leadership style building partnerships and collaborative environments.

**About Novartis:**

Our purpose is to reimagine medicine to improve and extend people's lives. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

**Benefits:**

  • Competitive salary.
  • Annual bonus.
  • Flexible working schedule, tailored to your needs.
  • Possibility to work from home.
  • Pension scheme.
  • Employee Recognition Scheme.
  • Expanded program for the promotion of health in the field of physical, mental and social well-being.
  • Unlimited learning and development opportunities.

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