Contribute to Global Clinical Trials at a Top 5 Multinational CRO
Lead Team of Biostatisticians across JAPAC Region
- Top 5 multinational Contract Research Organization specializing in Oncology and Neuroscience TAs
- Line management of staff including: performance management, progressive discipline, and training need identification.
- Recommends courses of action on salary administration, transfers, new hires, terminations, and professional development. Regularly communicates with staff on working practices, policies, and work instructions.
- Ensures that the local Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements, and identifies the need for contract modifications due to out of scope activities.
- Assigns Biostatisticians to projects in a manner which aims to keep associates at their utilization goal and which matches associates to projects appropriate to their skills, training, and experience, while also providing opportunities to work with varied projects, sponsors, and teams.
- Prioritizes activities across biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals which promotes teamwork and quickly restores department effectiveness.
- Responsible for staff development to facilitate succession planning and maintaining a biostatistics staff with diverse skills, abilities, and competencies meeting the business needs of Biostatistics department.
- Sets challenging, achievable goals for associates which contribute to department objectives and supports efforts to achieve those goals. Provides motivating, timely performance feedback to associates on a routine basis as well as for formal performance appraisals.
MS or PhD in Biostatistics or related field.
Extensive experience in clinical trials or equivalent combination of education and experience.
Experience with regulatory submissions preferred.
Management experience preferred.
Extensive knowledge of the drug development process and PMDA and ICH guidelines and demonstrated leadership ability.
Effective written and verbal communication skills.
Ability to apply knowledge of statistical design, analysis, and programming techniques used in clinical trials.
Ability to read, write, speak, and understand English.
- Ability to lead Japan operations from a biostatistics perspective
- Contribute to global clinical trials a cross APAC region
- Direct report line to global