Specialist I or II or Senior Specialist, Statistical Sciences in Japan Data and Statistical Sciences

企業概要

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

求人内容

Purpose Statement:

The position is responsible for providing support to Japan clinical development projects in the area of statistical sciences. The support is supplied in the context of a cooperative, one team mindset, project-oriented effort and included statistical capabilities in general planning and execution of clinical trials, statistical analysis and reporting of the data from individual trials, and regulatory submissions and inspections.

Major Responsibilities:

• Provide expertise to design, analysis and reporting of clinical trials or other scientific research studies. Develop protocols and statistical analysis plan. Implement sound statistical methodology in scientific investigations.
• Perform statistical analysis as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines.
• Develop strategy for data presentation and inference. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Identify scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. Partner with Data Science in preparing for database lock.
• Work collaboratively with multifunction teams. Clearly explain statistical concepts to non-statisticians. Provide responses to questions, and pursue analyses suggested by data. Build/drive cross-functional relationships and collaboration.
• Support for dealing with the authorities. Perform follow-up and analysis of clinical study data, based on requirements and comments from PMDA, and support preparation of response.

Key Stakeholders:

• Statistical Sciences and Programming Group Manager
• Statistical Sciences Unit
• Clinical Development Experts
• Japan Development Project Lead

職務目的

日本の臨床開発プロジェクトを統計的観点からサポートする責任を担う。臨床試験の計画及び実施，個々の試験から得られたデータの統計解析及び報告，並びに規制当局への承認申請及び査察に関する統計的知識及び経験により協調的かつ計画的な行動で臨床開発プロジェクトをサポートする。

主な責務

• 臨床試験又はその他の科学的研究に関する試験のデザイン，解析及び報告に対して統計的な知識を提供する。試験実施計画書及び統計解析計画書を作成する。科学的研究において適切な統計手法を用いて解析を実施する。
• 解析計画書に従って統計解析を実施する。統計プログラマーと協力し，合意されたスケジュールに従って適切な解析結果を確実に提供する。
• 解析結果の提示方法及び結果の解釈を検討し，科学的研究の学会発表や論文公表に協力する。報告書及び論文の正確性及び内部整合性を確保する。
• 科学的に適切なデータ収集手段を検討する。データの問題又は試験計画からの逸脱を特定し共有する。データベースロック実施のためにデータサイエンスのメンバーと連携する。
• プロジェクトチームと協力して業務を遂行する。他部署のメンバーに統計的な考え方を明確に説明する。質問に回答し，データに基づいて解析を検討する。他部署のメンバーとの協力関係を構築する。
• 当局との対応をサポートする。 PMDAからのリクエストや意見に基づいて臨床試験データの解析を実施し，回答作成をサポートする。

Key Stakeholders

• スタティスティカルサイエンス&プログラミング 部長
• スタティスティカルサイエンスユニット・マネジャー
• 臨床開発メンバー
• プロジェクトリーダー

資格

Qualifications:

• At least 5 years of experience in pharmaceutical R&D including at least 3 years’ experience in data management and/or statistical sciences and programming areas.
• A bachelor’s degree in or equivalent knowledge of statistics/mathematics, pharmacy, biology, pharmacology or related scientific field focused on quantitative skills. A master’s or doctor’s degree is more favorable.
• Proficient in English communication skills (TOEIC 650 or more or equivalent)
• Good leadership skills as defined by AbbVie core leadership behaviors.

• Good fit with the ways we work as per below.

All4OneAbbvie - Interpersonal Savvy

Relates well to all kinds of people, up, down, and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

Decide Smart&Sure - Dealing With Ambiguity

Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn’t upset when things are up in the air; doesn’t have to finish things before moving on; can comfortably handle risk and uncertainty.

Agile&Accountable - Managing Vision and Purpose

Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision shareable by everyone; can inspire and motivate entire units or organizations.

Clear&Courageous - Managerial Courage

Doesn’t hold back anything that needs to be said; provides current, direct, complete, and “actionable” positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation (not including direct reports) quickly and directly; is not afraid to take negative action when necessary.

Make Possibilities Real – Planning

Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process steps; develops schedules and task/people assignments; anticipates and adjusts for problems and roadblocks; measures performance against goals; evaluates results.

Qualifications:

• 5 年以上の医薬品開発の経験
• 3年以上のデータマネージメント，統計科学又は統計プログラミングに関する業務経験
• 統計/数学，薬学，生物学，薬理学，または関連分野の学士号または同等の知識（修士号または博士号尚可）
• 英語でのコミュニケーション能力（TOEIC650点以上または同等の能力）
• Abbvie core Leadership behaviorに基づいた優れたリーダーシップスキル

その他の情報

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。