Principal Biostatistician


Dublin 4, Ireland

Application Deadline

The Principal Biostatistician will be responsible for delivering statistical analytic solutions for Medical Affairs studies (MA), Non-Interventional studies (NIS), Scientific Analytics studies and multiple Phase I-IV clinical trials at a trial level by executing statistical analyses plans, ensuring high quality and timely production of statistical reporting deliverables (analysis datasets, tables, listings and graphs). Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, analyses and data exploration at the study level. Is also responsible for the training and mentoring of other statisticians and supporting project operational excellence.

Your responsibilities:

Your responsibilities include, but are not limited to:

  • Responsible and accountable for the statistical activities and support on statistical solutions for studies/publications and conferences and support the tasks independently seeking peer inputs/ reviews as required. Activities include protocol development in alignment with the development plan, providing inputs on statistical scientific and operational aspects of the planning, design and reporting of trials/experiments, and production and delivery of statistical deliverables and exploratory analyses. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
  • Lead statistical/numerical/analytic research by providing advice and solutions on computational aspects of the problem.
  • Guides the trial statistician to ensure that documents, specifications, programs/macros are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for MA studies, NIS and Scientific Analytic studies.
  • Assume responsibility for reporting and analysis execution for multiple studies. Responsibilities include, leading statistical deliverable meetings with necessary clinical trial team members and third parties, and exploratory analyses for ad-hoc analyses. Expected to provide support for publications for individual clinical trials, and scientific analytical solutions.
  • Oversee Biostatistics resources and deliverables for assigned trials and therapeutic area level. Lead study teams to ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.
  • Explain statistical methodology and interpret analysis results. Provide statistical expertise to support all activities and documents, meetings with and responses to customers and JOC meeting activities, as required.
  • Maintain efficient interfaces with Lead Statistician, internal and external customers with support of CTS management, CROs and CPOs as needed.
  • Take lead role to collaborate with other line functions including the clinical trial team. Explain statistical concepts in a manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
  • Participate in non-clinical project activities as needed. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer re-viewed journals and presentations at professional meetings.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

What you’ll bring to the role:

  • MS/ MSc (in Statistics or equivalent) with 8+ years relevant work experience or PhD (in Statistics or equivalent) with 5+ years of work experience
  • Excellent knowledge of/experience with SAS/ R/ Splus or any other business or research analytic software with an expertise in at least one software.
  • Good understanding of global clinical trial practices, procedures, methodologies and deep knowledge of data architecture
  • Statistical and numerical knowledge and expertise in analytic aspects and applications in clinical trials.

Desirable requirements:

  • Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.
  • Good understanding of drug development, regulatory requirements, ICH and HA guidelines

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Novartis?

766 million. That’s how many lives our products touched in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do at Novartis!

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