Principal Statistician
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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FDAEMAPMDACDE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SASRおよびサンプルサイズやシミュレーションソフト例EASTnQueryWinBugs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 organizations 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
- Masters 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 8500 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent 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 thats 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 . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Required Experience:
Staff IC
Key Skills
- Spss
- R
- Regression Analysis
- Stata
- Survival Analysis
- Clinical Trials
- Statistical Software
- Data Mining
- SAS
- Statistics
- Data Analysis Skills
- Statistical Analysis
About Company
UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We're here because we want to transform patients’ lives by pushing the boundaries of what is possible.To achieve our ambition, we w ... View more
