Job Description

• The Biomarker Biostatistician is involved in the clinical development process from early on to lead the statistical aspects of the biomarker discussions as part of the clinical project team and is responsible for generation actionable data-driven insights from clinical biomarkers to optimize targeted patient population and increase the productivity of drug development in one or more therapeutic areas (e.g., oncology, immunology & inflammation, neurology, rare disease, and rare blood disorders).

Responsibilities

As a Principal Biostatistician, your responsibilities will include:

• Lead in multiple complex projects / one or several indications of a project in clinical development phases with regard to statistical activities in Precision Medicine and Biomarker activities.
• Leverage biomarker data/evidence from different sources (e.g., pre-clinical data, RWE, publications) and provide appropriate input for the development of the biomarker strategy of a clinical project in collaboration with project team members.
• Implement innovative data analytical tools (e.g., AI, machine learning) and statistical methodologies to transform the complex biomarker data into insights that can be readily used in drug development.
• Planning, analyzing, and reporting of various of biomarker data (e.g., biomarker profiles, genome-wide datasets, medical imaging data, continuous data from wearable devices) collected from clinical studies for both formal reporting and exploratory analyses purposes.
• Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
• Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment.
• Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas. Capacity to respond to unscheduled increase in project workload. Ensure project team compliance with SOPs and departmental standards.
• Represents statistics in regulatory discussions and meetings for biomarker topics
• Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross-functional initiatives
• Provide technical guidance and mentoring to junior staff.

Qualifications

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:

• PhD/MS in statistics or related discipline with a minimum of 6 years of pharmaceutical experience
• Demonstrated strong study management, interpersonal and communication skills
• Broad knowledge and good understanding of advanced statistical concepts and techniques in various biomarker data collected in clinical studies
• General knowledge of pharmaceutical clinical development and the process of clinical decision making; experience of using biomarker data in clinical decision-making process is desired
• Broad Biomarker knowledge
• Proven experience in clinical development, interactions with regulatory agencies or other external stakeholders is desired