The Cancer Clinical Research Unit (CCRU) at the Princess Margaret Cancer Centre has a mandate to lead and promote clinical research within the Princess Margaret (PM) Cancer Centre through standardization of processes and encouraging a culture of responsibility and accountability in clinical trials. Working under the direction of the CCRU Program Director, the Department of Biostatistics Manager will be responsible for providing statistical leadership for the overall program and departmental staff. As a strong individual contributor, demonstrating leadership qualities, creative and strategic thinking and knowledge of cutting-edge clinical trial design and methodology, the manager will be responsible for the day-to-day operations of the department; managing and distributing workload, and performance, conducting annual performance reviews, hiring of new staff, development of SOPs, budget preparation, and overseeing cost recovery. In addition to the administrative aspects of the role the manager will also dedicate approximately half of their time as a collaborating/consulting biostatistician. Responsibilities include ensuring statistical integrity of clinical research project deliverables, leading research design and protocol development, statistical analysis plans, advising on data collection, analyzing data, interpreting and reporting results and preparing and revising manuscripts.
Working under the direction of the CCRU Management, the Manager of Biostatistics will conduct key tasks including:
• Contribute to study level tasks from a statistics perspective including: participate in study design, sample size determination, author/review statistics section of the protocol, author/review SAP and other biostatistics related study documents.
• Mentoring new staff
• Ensure statistical integrity of project deliverables, review and sign-off on key documents
• Coordinate with SAS programming staff to perform quality control as applicable
• Identify risks/gaps and work with cross-functional teams to resolve or follow-up
• Lead the development of standards and SOPs within department
• Independently conduct exploratory analysis as needed; propose leading edge appropriate methodological approaches to improve the efficiency of study results
• Master’s or PhD degree in Biostatistics or equivalent
• Minimum five (5) years of statistical consulting using SAS or R, oncology experience an asset
• Solid clinical trial statistical experience
• Excellent written and verbal English language skills
• Ability to review and understand data from multiple sources
• Understanding of regulatory (e.g., FDA, HC, ICH) requirements
• Ability to understand responsibilities of other functional areas (data management, medic writing, statistical programming, clinical) and work with their representatives
• Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability to learn quickly and work independently
• Ability to work under pressure and attention to detail.
• Ability to perform multiple concurrent tasks
• Knowledge of applicable legislative, UHN and/or departmental policies
• Client service oriented, with the ability to effectively work with diversity and appreciate that people with different opinions, backgrounds and characteristics bring richness to the challenge or situation at hand.
JOB POSTING # 813850