［Alexion Japan］Senior Manager, Biostatistics
You will be responsible for:
- Collaborates with 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 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 and analysis of trial data. Writes and/or reviews ADS and ad hoc analysis specifications
- 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.
- 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.
You will need to have:
- 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
- Flexible, well-organized, and possess the ability to work well under pressure.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- PhD in Statistics/Biostatistics preferred.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.