Make your mark for patients

(English Follows Japanese)

【チームについて】
あなたが所属するチームは、グローバルおよび東アジア地域の臨床開発を支えるバイオメトリクス&データサイエンス部門です。国内外の多様な専門家と協力し、革新的な統計解析やデータサイエンスの手法を用いて、グローバルレベルでの医薬品開発の質と効率向上に貢献しています。患者さんにとっての価値を創造するため、チームは常に新しい知識やスキルの習得を重視し、協働と成長を促進する環境です。 
【主な業務内容】
・開発化合物に対し、バイオメトリクス&データサイエンス部門の代表として、統計的観点からの開発戦略を含むプログラム全体を支援する
・統計関連の成果物に対する責任をもち、国内外のプロジェクトチームの意思決定に寄与する
・バイオメトリクス&データサイエンス部門の継続的なイノベーションとスキル向上の文化醸成に貢献する
・社内外で部門の代表として活動し、業界をリードしながら、組織の評判向上に寄与する
・医薬品開発におけるトレンド(RWDの活用、Complex innovative design等)を把握し、戦略の提案・実行につなげる
・統計担当者の立場から申請準備や規制当局とのやり取りを行い、承認取得に貢献する
【応募資格】
・統計学または生物統計学分野の修士号または博士号
・臨床試験の統計担当者として6年以上の実務経験
・少なくとも1つの規制当局(例:FDA、EMA、PMDA、CDEなど)への申請および承認経験
・国内外のステークホルダーとの調整・交渉をおこなえる優れた書面および口頭でのコミュニケーション力
・最新の統計手法に関する議論に対応できる柔軟性および専門性
・自発的に行動し、戦略から実務まで遂行できる実行力
・統計プログラミング言語(例:SAS、R)およびサンプルサイズやシミュレーションソフト(例:EAST、nQuery、WinBugsなど)に精通
・プログラマーと協業するためのCDISC標準(SDTM/ADaM)に関する知識
・チームリーダー経験(例:統計チーム(またはプログラミングチーム)のマネジメント経験)があれば尚可
【応募方法】
・日本語と英語の履歴書を1つのファイルにまとめ、当社システムにアップロードしてください
・UCB社員からの紹介や知人がいる場合は、応募時にシステム上でその旨を記載してください

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【About Our Team】

You will be part of the Biometrics & Data Sciences (BDS) department, which supports global clinical development. By collaborating with diverse experts both within Japan and internationally, our team leverages innovative statistical and data science methodologies to enhance the quality and efficiency of drug development on a global scale. With a strong focus on creating value for patients, our team emphasizes continuous learning of new knowledge and skills, fostering an environment that promotes collaboration and growth.

【Key Responsibilities】

• Serve as a representative of the Biometrics & Data Sciences department for development compounds, supporting the overall program including development strategies from a statistical perspective.
• Take accountability for statistical deliverables and contribute to decision-making within domestic and global project teams.
• Contribute to fostering a culture of continuous innovation and skill development within the Biometrics & Data Sciences department.
• Act as a representative of the department internally and externally, helping strengthen the organization's reputation while taking a leadership role within the industry.
• Stay abreast of trends in drug development (e.g., use of RWD, complex innovative designs) and propose and implement strategies accordingly.
• Support submission preparation and interactions with regulatory authorities from the statistical perspective, contributing to successful approvals.

【Qualifications】

• Master's or Ph.D. in Statistics or Biostatistics.
• At least 6 years of hands-on experience as a statistician in clinical trials.
• Proven experience in submissions and approvals with at least one regulatory authority (e.g., FDA, EMA, PMDA, CDE).
• Excellent written and verbal communication skills with the ability to coordinate and negotiate with stakeholders across countries.
• Flexibility and expertise to engage in discussions on the latest statistical methodologies.
• Proactive attitude with the ability to execute from strategy through to operations.
• Proficiency in statistical programming languages (e.g., SAS, R) and sample size/simulation software (e.g., EAST, nQuery, WinBUGS).
• Knowledge of CDISC standards (SDTM/ADaM) for effective collaboration with programmers.
• Team leadership experience (e.g., managing a statistics or programming team) is a plus.

【How to Apply】

• Please combine your resume in both Japanese and English into a single file and upload it to our application system.
• If you have been referred by a UCB employee or have contacts within the company, please indicate this information in the system at the time of application.

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you 

About us 
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

Why work with us? 
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.