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 Alexion 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
The qualified applicant must also be flexible, well-organized, and possess the ability to work well under pressure.
- A PhD in Statistics/Biostatistics is preferred
Location: Tokyo, Tokyo, JP
Posted Date: 4/17/2021