Senior Manager of Biostatistics in Biopharma

4 weeks ago

London, Greater London, United Kingdom Emmes Full time

This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.

Director of Biostatistics in Biopharma - Remote

UK or EU Remote

The Emmes Company, LLC ("Emmes") is a worldwide, comprehensive Clinical Research Organization committed to excellence in fostering the progress of public health and biopharmaceutical advancements. We uphold the principle of truth, which is the foundation of our company name, Emmes, meaning truth. Our extensive experience has taught us that collaborative partnerships flourish and human health improves when truth guides our endeavors.

Our culture, characterized by "Character Achieves Results," is driven by five core values that shape our actions in research and set us apart as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships, and Intellectual Curiosity. We are a reliable partner to clients who share our commitment to enhancing public health amidst the evolving landscape of scientific research.

If you resonate with our motivations and enthusiasm for research, we invite you to join us. You will become part of 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 acts as a leader within the global biostatistics division, responsible for strategic and operational management of biostatistical and statistical programming activities for Emmes' biopharma portfolio across key therapeutic areas, including vaccine and infectious diseases, ophthalmology, CNS, rare diseases, and cell and gene therapy, among others. This role is integral to Emmes' biopharma leadership team, ensuring high-quality, timely, and budget-compliant statistical deliverables while supporting business development efforts for prospective biopharma projects.

Responsibilities

  • Design clinical development strategies, clinical trial protocols, and statistical analysis frameworks in collaboration with our biopharma partners.
  • Oversee statistical deliverables, including execution of statistical analyses, interim safety and efficacy reports, clinical study documentation, and scientific manuscript preparation.
  • Build and maintain collaborative relationships with Sponsors and Emmes project teams, serving as the primary contact for project statistical deliverables.
  • Represent Emmes at Sponsor, Regulatory, Investigator, or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings).
  • Stay informed of and ensure adherence to regulatory standards (e.g., FDA, EMA, and ICH guidelines) and industry data standards (e.g., CDISC).
  • Attend and present at external statistical conferences and workshops, establishing thought leadership in the biostatistics domain.
  • Utilize knowledge of advanced biostatistical methodologies and current industry trends to identify and implement best practices in biostatistics.
  • Ensure successful delivery of biostatistics and statistical programming services to Emmes' biopharma clients, managing budgets, timelines, and quality of biostatistical deliverables.
  • Collaborate with global department leadership to ensure adequate resources are available to support Emmes' biopharma portfolio.
  • Act as an escalation point for biostatistics-related client, quality, or budget issues for biopharma projects, resolving concerns or escalating appropriately to global biostatistics and biopharma leadership.
  • Lead statistical-only or limited scope projects, managing budgets, timelines, deliverables, and change orders.
  • Drive biopharma-related business development initiatives on behalf of the global biostatistics department, including proposal and budget development, as well as bid defense support.
  • Represent the global biostatistics department as a member of Emmes' biopharma leadership team and contribute to the global biostatistics leadership team.
  • Provide input into professional development and technical training standards for the global biostatistics department.
  • Independently lead cross-functional interactions and initiatives with other departments and global entities, ensuring clear and open communication with groups outside the global biostatistics department.
  • Effectively supervise biostatistics and statistical programming staff, providing mentorship, feedback, and conducting performance evaluations.
  • Participate in recruitment activities for new biostatistics department staff and contribute to hiring decisions.
  • Encourage staff engagement and participation across the global biostatistics department, focusing on support for biopharma projects.
  • Proactively identify high-performing staff and offer mentorship and opportunities for career advancement.
  • Perform other duties as assigned.

Qualifications

  • MS or PhD in Biostatistics, Statistics, or Epidemiology.
  • Typically possesses 12+ years of experience with a PhD or 15+ years of experience with an MS degree in a biostatistics environment.
  • Management experience, including interaction with executive leadership and supervision of experienced biostatisticians and statistical programmers.
  • Experience leading biostatistics-related activities in the biopharma sector or in a CRO setting for biopharma clients.
  • Demonstrated leadership and project management capabilities.
  • Proven ability to develop strategies for future growth, establish goals, and communicate and implement strategies effectively.
  • Ability to lead and build effective teams while fostering collaboration across diverse groups or functions within the organization.
  • Demonstrated problem-solving and analytical skills, combined with sound business judgment.
  • Impeccable integrity as a leader and role model.
  • Ability to communicate technical concepts effectively, both in writing and verbally.
  • Strong interpersonal and communication skills necessary for interfacing with all levels of management.

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