【Alexion Japan】Senior Manager, Biostatistics

This is what you will do: 
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 development strategies, trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. 

You will be responsible for:

・Collaborates with Global Biostatistics, Japan Clinical Development, Clinical Pharmacology, Regulatory and Clinical Operations expertise areas to design clinical trials and to plan development strategies.

・Writes and/or reviews 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, CTDs 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 Senior Manager, Biostatistics Location: Tokyo, Japan Reports To: Director, Sr. Director or Executive Director, Biostatistics

・ 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.

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.