Director Biostatistics

2 months ago

London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full time

Influences and drives statistical strategy/innovation at an advanced expert level, directly taking part in cross-functional collaboration & decision making for multiple programs across multiple indications/therapeutic/disease areas within (pre/early/full) clinical development and/or medical affairs. Responsible for leading and integrating input from different quantitative scientists, impacting clinical development and health authority interactions. Represent the function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational, and scientific leadership and solutions. About the Role

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.

We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together

The Role:

We are seeking a highly skilled and motivated individual to join our team as Director Biostatistics. You will be required to influence and drive statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) across (pre/early/full) clinical development and/or medical affairs. You will be responsible for leading and integrating input from different quantitative scientists across the development lifecycle while impacting clinical development, health authority interactions, and strategic decisions that need to be made across the lifecycle of our products. You will represent the Biostatistics function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational, and scientific leadership and solutions to the organization.

May serve as:

Global Program Biostatistics Head for a mid to high complexity project and/or Lead Statistician for multiple pre/early clinical/CP projects.

Key requirements:

  1. Ensure expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with health technology assessment (HTAs) organizations, influence and implement publication strategies, quantitative decision making) for critical clinical studies in a drug development program.
  2. Accountable for strategic statistical input and influence into one or more drug development projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).
  3. Lead collaborations with strategic functions within the global program teams (GPTs) to drive quantitative decision making in drug development and enable successful impact on robust drug development plans.
  4. Facilitate flawless transition of projects from early to full development, proposing and implementing innovative designs and methods to optimize drug development lifecycle.
  5. Plan, prioritize and oversee project level activities and ensure efficient resource management within development unit and effective partnership with external vendors.
  6. Represent Biostatistics and Pharmacometrics line function at internal and external decision boards.
  7. Significantly contribute to project team preparation and play a prominent role representing Biostatistics at HA Advisory Committees and meetings.
  8. Lead or significantly contribute to initiatives at global line function level, or cross-functional level and across external professional associations and consortia, requiring coordination of diverse team members with wide-ranging technical and non-technical skill sets.

Your Experience:

  1. MS Statistics or equivalent with 12+ years’ work experience or PhD (in Statistics or equivalent) with 8 years+ work experience.
  2. Fluent in English with strong communication and presentation skills, with the ability to articulate complex concepts to diverse audiences.
  3. Influences decisions that directly impact the project and department’s ability to deliver objectives.
  4. Has advanced knowledge and expertise of applying statistics and innovative approaches. Expert knowledge in a variety of statistical areas which may include exposure-response modelling, applied Bayesian statistics, exploration of high-dimensional data, and complex innovative designs.
  5. Record of successful implementation of novel methods and/or innovative strategies in drug development.
  6. Extensive knowledge of drug development and HA guidelines.
  7. Strong understanding of at least one disease/therapeutic area.
  8. Proven leadership ability with excellent collaboration skills and ability to mentor and provide oversight for up to 10 associates.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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.

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up.

Division: Development

Business Unit: Innovative Medicines

Location: United Kingdom

Site: London (The Westworks)

Company / Legal Entity: GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Functional Area: Research & Development

Job Type: Full time

Employment Type: Regular

Shift Work: No

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