Alexion JapanSenior Manager, Biostatistics

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

This is what you will do:
The Senior Manager Biostatistics is responsible for statistical activities in support ofclinical trials and NDA submission including but not limited to the following:contributing to development strategies trial designs authoring statistical sections ofprotocols preparing statistical analysis plans and reviewing and interpreting theanalysis 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

11-3月-2026

Closing Date

30-7月-2026

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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.

Required Experience:

Senior Manager

This is what you will do:The Senior Manager Biostatistics is responsible for statistical activities in support ofclinical trials and NDA submission including but not limited to the following:contributing to development strategies trial designs authoring statistical sections ofprotocols preparing sta...