Managing Consultant, Designing Innovative Clinical Trial Designs

Managing Consultant, Designing Innovative Clinical Trial Designs

Cytel

United Kingdom

We are hiring a Managing Consultant to join our Innovative Statistical Consulting Practice. As a seasoned Biostatistician, you will leverage and broaden Cytel’s reputation for thought leadership and innovative services by leading engagements for pharmaceutical, biotech and device clients, and building and maintaining successful long-term relationships with clients in collaboration with Cytel’s business developers and other personnel related to the account. This includes developing and demonstrating thought leadership in statistical methodology for clinical development, ensuring that Cytel remains at the leading edge, and raising Cytel brand awareness and recognition throughout the industry.

Specifically, we are looking for leaders with a strong foundation in statistics plus broad expertise and/or unique knowledge in related areas (adaptive designs, clinical development, data science), to provide strategic advice to define optimal regulatory, clinical and/or market access pathways and promote faster patient access to better health technologies.

Specific duties and responsibilities:

  • Lead/Manage projects in innovative statistical designs and analytics. Ensure specified deliverables are developed on budget and undergo appropriate review and sign off. Responsible for the successful integration of the team on projects, quality of deliverables and the project team’s efficiency. This includes mentoring and training of junior staff.
  • Leadership or significant contributions to scientific processes involved with client deliverables (e.g., stat. methodology, analysis plans, development of internal software/tools).
  • Build and maintain successful long-term relationships with clients and/or academia/external research community. Routinely identify opportunities for follow on work.
  • Keep abreast with regulatory, reimbursement and other industry requirements and guidelines, including via active participation in scientific conferences and symposia.
  • For assigned accounts or areas of expertise, act as a subject matter expert, working with other consultants and associates working on the account or in the area, with the goal of representing Cytel organization.
  • The position may require occasional travel, substantial direct contact with senior management and executives at prospects and existing clients, and the ability to build and leverage strong interpersonal business relationships both internally and externally to Cytel.

Qualifications and Experience:

  • Minimum of a Masters in Mathematics, Biostatistics, or a related field; PhD, or advanced degree highly desirable; 10-15 years of experience in the clinical trials or health research environment.
  • Strong interpersonal skills with the ability to gain respect of and influence the management team, board members, and client personnel at all levels.
  • Thorough understanding of the biopharmaceutical R&D process in combination with solid business acumen and an appreciation of the broader business issues.
  • Strategic thinker with a global orientation, strong problem-solving and analytical skills, and the ability to execute in complex situations at the tactical level. Proven management skills with the ability to build, mentor and motivate a strong team of consultants and analysts.
  • Experience interacting with regulatory agencies (FDA/EMA) and key opinion leaders to enhance development plans.
  • Collaborative, entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment.

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