Lead Biostatistician for Biopharmaceuticals

3 weeks ago

London, Greater London, United Kingdom Emmes Full time

This opportunity is presented by Jobs/Redefined, the UK's premier job board focused on inclusivity for individuals over 50.

Director of Biostatistics in Biopharma - Remote

Remote within the UK or EU

The Emmes Company, LLC ("Emmes") is a worldwide, comprehensive Clinical Research Organization committed to excellence in promoting public health and biopharmaceutical advancements. Our name, Emmes, which signifies truth, reflects our belief in the importance of integrity. Over the years, we have recognized that collaborative partnerships flourish and human health improves when truth guides our endeavors.

Our culture, defined by the motto "Character Achieves Results," is anchored by five core values: Integrity, Agility, Passion for Excellence, Collaborative Partnerships, and Intellectual Curiosity. We pride ourselves on being a reliable partner to clients who share our dedication to enhancing public health amidst the evolving landscape of scientific research.

If you resonate with our mission and enthusiasm for research, we invite you to become part of our team. You will be welcomed into a collaborative environment that empowers every Emmes employee—from entry-level to executive—to contribute to our clients' success through open and honest idea sharing.

Primary Purpose

The Director of Biostatistics in Biopharma plays a pivotal role within the global biostatistics department, overseeing strategic and operational aspects of biostatistical and statistical programming functions for Emmes' biopharma portfolio. This includes key therapeutic areas such as vaccines, infectious diseases, ophthalmology, CNS, rare diseases, and cell and gene therapies. As a member of Emmes' biopharma leadership team, this role ensures the delivery of high-quality, timely, and budget-compliant statistical outputs while supporting business development initiatives for prospective biopharma projects.

Key Responsibilities

  • Develops clinical development strategies, trial protocols, and statistical analysis plans in partnership with biopharma collaborators.
  • Oversees statistical deliverables, including execution of analyses, interim safety and efficacy reports, clinical study reports, and scientific manuscript preparation.
  • Builds collaborative relationships with sponsors and Emmes project teams, acting as the primary contact for statistical deliverables.
  • Represents Emmes at sponsor, regulatory, investigator, or safety review meetings.
  • Maintains knowledge of and ensures adherence to regulatory standards and industry data protocols.
  • Participates in and presents at external statistical conferences, establishing thought leadership in biostatistics.
  • Utilizes expertise in advanced biostatistical methodologies to identify and implement best practices.
  • Ensures successful delivery of biostatistical services to Emmes' biopharma clients, managing budgets, timelines, and quality.
  • Collaborates with global leadership to ensure adequate resources for Emmes' biopharma initiatives.
  • Acts as an escalation point for client, quality, or budget issues related to biopharma projects.
  • Leads statistical-only or limited scope projects, managing budgets, timelines, and deliverables.
  • Drives business development efforts for the global biostatistics department, including proposal and budget development.
  • Represents the global biostatistics department within Emmes' biopharma leadership team.
  • Contributes to professional development and training standards for the global biostatistics team.
  • Facilitates cross-functional interactions and initiatives, ensuring clear communication with external groups.
  • Supervises biostatistics and statistical programming staff, providing mentorship and conducting performance evaluations.
  • Participates in recruitment activities for new staff and contributes to hiring decisions.
  • Encourages staff engagement and participation across the global biostatistics department.
  • Identifies high-performing staff and offers mentorship and career development opportunities.
  • Performs additional duties as assigned.

Qualifications

  • MS or PhD in Biostatistics, Statistics, or Epidemiology.
  • Typically requires 12+ years of experience with a PhD or 15+ years with a MS degree in a biostatistics context.
  • Management experience with executive leadership and supervision of seasoned biostatisticians and statistical programmers.
  • Experience leading biostatistics activities in a biopharma or CRO environment.
  • Proven leadership and project management capabilities.
  • Ability to formulate strategies for growth, set objectives, and effectively communicate and implement plans.
  • Skilled in leading and building effective teams and fostering collaboration across diverse functions.
  • Strong problem-solving and analytical abilities, coupled with sound business judgment.
  • Exemplary integrity as a leader and role model.
  • Effective communication of technical concepts, both written and verbal.
  • Strong interpersonal skills for engaging with all management levels.

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