- Applicants must have permission to work in Japan
- Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
Sr. Manager Biostatistics
Global Pharmaceutical Company
The Senior Manager Biostatistics is responsible for statistical activities in support of clinical trials and NDA submission, including but not limited to the following: contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.
- Collaborates with Japan and Global-Biostatistics, Clinical Development, Clinical Pharmacology, Regulatory and Clinical Operations expertise areas to design clinical trials.
- Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts
- Contributes to or prepares statistical analysis plans and Data Presentation Plans
- Collaborates with Japan and Global-Biostatistics, Data Management, Clinical Development, Clinical Pharmacology and Clinical Operations on design of eCRFs
- Provides statistical guidance on conduct of ongoing trials
- Collaborates with Statistical Programmers on summary
- Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
- Contributes to scientific articles, summarizing data collected in trials.
- Contributes to or prepares marketing applications (NDA) to regulatory agency.
- Participates in other activities and meetings to support Biostatistics and the Global Program Team as needed.
- Consults with Research & Preclinical colleagues on statistical questions in their work.
- Manages CRO statistical and programming support.
- PhD in Biostatistics, Statistics, or equivalent with at least 4 years pharmaceutical biostatistics experience or MS with at least 6 years of relevant experience.
- Excellent written and oral communication skills
- Excellent presentation and interpersonal skills
- Experience programming in SAS
- Experience with simulations (design, implementation and interpretation)
- Understanding of ICH GCP as well as general knowledge of industry practices and standards
- Familiarity with R programming language and other statistical software, including EAST
- Experience with CDISC, including SDTM, ADaM, CDASH
Seniority Level：Mid Senior Level
Job Function: Analyst, Management