- Design and Execute Biostatistic Aspects of Clinical Studies in Japan
- Lead Team of Statisticians on a Project Basis
- Well known global biopharmaceutical company with rich development pipeline and diverse product portfolio in Oncology, Neuroscience, Infectious Disease, Metabolic Disease areas.
- Provide statistical expertise in clinical development programs, development strategy, study design, data analysis and interpretation of results for clinical trials;
- Contribute to develop clinical development programs, development strategy and study design, in terms of statistical viewpoint, based on advanced TA/DA knowledge.
- Support broad implementation of innovative statistical approaches across the development portfolio.
- Support development and implementation of innovative approaches, participating in their hands‐on implementation through direct interactions with statisticians. This involves, but is not limited to, identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods under a range of scenarios; and participating in the implementation of the selected approaches by engaging in protocol and SAP write‐up.
- Participate in training and presentations on innovative approaches across the R&D organization (including statisticians, pharmacometricians, clinicians, and other stakeholder groups) to ensure awareness and adequate knowledge about these methods. Keep up‐to‐date knowledge of designs and analysis methods for clinical trials, including adaptive designs, model‐based methods, etc.
- Collaborate with external consultants to provide support in the development and implementation of innovative methods and designs.
- May engage in external collaborations within professional associations, participating in working groups, program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals
- Identify opportunities for innovation; interact directly with statisticians and other QS scientists (including global QS) for early identification of opportunities for innovative approaches.
- Contribute people development through coaching and advices with line managers in Biostatistics dept.
- Ideally MS or PhD in Statistics, or equivalent amount of experience the pharmaceutical industry including design, analysis, and reporting of clinical studies.
- Significant experience with regulatory submissions and interactions with regulatory agencies.
- Extensive experience with the design, analysis, and reporting of Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting.
- Demonstrated leadership skills as biostatistics lead on multiple clinical programs.
- Hands-on experience with developing detailed statistical analysis plans and designing tables, figures, and listings for clinical study reports.
- Knowledge of current topics and issues related to the design and analysis of clinical studies, including adaptive designs, multiplicity, handling of missing data, and sensitivity analyses.
- Strong oral and written communication, as well as problem-solving skills, are essential; ability to proactively identify issues and determine appropriate solutions to complex problems.
- Excellent working knowledge of the SAS software package; ability to communicate effectively with SAS programmers, review SAS output, and write SAS code as needed.
- Strong working knowledge of current regulatory requirements related to the submission of clinical study data and statistical programs.
- Experience in the development of integrated summaries of safety and efficacy. Demonstrated expertise in implementation of CDISC standards applicable to regulatory submissions.
- Ability to handle multiple projects at one time and direct resources appropriately to address frequent changes in priorities.
- Fluent English and Japanese skills
- Opportunity to lead biostatistics projects at a country level within a major global biopharmaceutical company