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Head of Biostatistical Strategy

2 months ago

London, Greater London, United Kingdom Novartis Full time
Overview

The Director of Biostatistics plays a pivotal role in shaping and advancing statistical methodologies within the organization. This position entails active participation in cross-functional collaboration and decision-making processes across various programs and therapeutic areas throughout the clinical development lifecycle and medical affairs. The individual will lead and harmonize contributions from diverse quantitative experts, influencing clinical development strategies and interactions with health authorities.

Key Responsibilities:

  • Collaborate with the Head of Clinical Data Science to establish standards and automation strategies across the organization.
  • Oversee global teams tasked with implementing data standards and automation goals.
  • Ensure the deployment of high-quality, scalable, and regulatory-compliant data standards and technologies in partnership with industry peers and internal stakeholders, maintaining a strong customer focus.
  • Plan and manage KPIs, frameworks, policies, and processes for the development and maintenance of data standards.
  • Ensure the organization achieves a return on investment in the standards and automation landscape.
Role Insights

Our Development Team is driven by a mission to transform medicine for the betterment of patients' lives.

We are enhancing our processes and investing in innovative technologies to build robust therapeutic areas and capabilities, all aimed at expediting the delivery of our medicines to patients.

We are in search of exceptional talent to contribute to this mission and help create a hopeful future for individuals facing health challenges.

Responsibilities Include:

  • Serving as the Global Program Biostatistics Head for complex projects or as the Lead Statistician for multiple clinical projects.
  • Acting as a thought leader in biostatistics within drug development across various indications and engaging with the broader scientific community.

Essential Qualifications:

  • Contribute expert-level insights to the design, analysis, interpretation, and reporting of critical clinical studies.
  • Accountable for strategic statistical input into drug development projects, including regulatory and publication strategies.
  • Foster collaborations with strategic functions within global program teams to enhance quantitative decision-making in drug development.
  • Ensure seamless project transitions from early to full development while proposing innovative designs to optimize the drug development lifecycle.
  • Oversee project-level activities and manage resources effectively in collaboration with external partners.
  • Represent the Biostatistics function at internal and external decision-making boards.
  • Play a significant role in project team preparations and represent Biostatistics at health authority advisory committees.
  • Lead or contribute to initiatives at a global level, coordinating diverse teams with varying technical and non-technical skills.

Your Background:

  • MS in Statistics or equivalent with over 12 years of experience, or a PhD in Statistics with at least 8 years of experience.
  • Proficient in English with strong communication skills, capable of conveying complex ideas to varied audiences.
  • Proven ability to influence decisions impacting project outcomes and departmental objectives.
  • Advanced knowledge in statistical applications, including exposure-response modeling and innovative design methodologies.
  • Demonstrated success in implementing novel methods in drug development.
  • Comprehensive understanding of drug development processes and health authority guidelines.
  • Familiarity with at least one therapeutic area.
  • Strong leadership capabilities with experience mentoring teams.

Commitment to Diversity & Inclusion: The organization is dedicated to fostering an inclusive work environment that reflects the diversity of the patients and communities served.