[R&D] Statistician, バイオメトリクス・データマネジメント統括部 統計担当者
- Japan - Tokyo
職務概要
臨床試験のデザイン・分析・解釈を、関連する薬事規制要件、標準業務手順書（SOP）、およびベストプラクティスに従って業務を行う。
臨床開発チームの中で特に（臨床開発リーダー、臨床薬理担当者、統計担当者）で効果的に協働し、科学に基づいた統計の専門知識を生かし、医薬品開発に貢献する。
職務内容
- 試験デザイン、統計解析計画、統計解析結果の解釈、医薬品の開発計画、規制当局対応、市販後の有効性・安全性エビデンス創出に対し、科学的に適切な統計的助言を提供する。
- 統計解析、解析結果、科学的な報告書（主要な統計解析結果の即時報告書、治験総括報告書等）の計画・作成・報告を担当し、臨床試験結果の解釈、論文作成や学会発表の支援、規制当局からの照会事項対応を行う。
- 担当プロジェクト（担当する医薬品開発）における臨床試験および承認申請に必要な統計関連成果物に責任を持ち、計画に従って納期と品質を確保する。
- 担当プロジェクトにおいて、米国本社の治療領域（TA）統計担当者とコミュニケーション・協働を行う。
- 臨床開発チーム内外の関係者（社内の業務関連部門、国内外の規制当局および製薬業界関係者・アカデミア組織）と効果的な協力関係を構築する。
- すべての臨床試験およびプロジェクトレベルの統計業務が、関連する規制要件および会社のSOPに準拠していることを保証する。
- 割り当てられたカリキュラムに基づき、すべてのSOPトレーニングを実施し、遵守状況を最新に保つ。
- 他の統計担当者、データマネージャー、臨床プログラミング担当者と協働し、部署横断で統計的助言とリーダーシップを提供する。
- 統計成果物に適用されるすべての品質プロセスおよび会社のデータ基準を遵守し、統計的助言が必要なプロセスに貢献する。
- 規制や専門分野で強い統計的プレゼンスを発揮し、規制ガイドラインの内容やその実務での解釈に影響を与える。
- 臨床試験への統計手法の応用に関する研究を積極的に推進する。これには米国本社の統計担当者との協業を含む。
必要な資格・スキル
行動スキル
- 組織内外の同僚や関係者と効果的にコミュニケーションできる口頭および書面によるコミュニケーション能力
- コンサルティングスキル
- 部署横断的に統計担当者としてリーダーシップを発揮する能力
技術スキル
- 臨床試験への応用に関する高度な統計スキル
- 医薬品開発に関する幅広い理解
- 臨床医学および規制要件に関する知識
学歴・資格
- 統計学、生物統計学、または関連分野の学位（修士号以上）
言語
- 米国本社TA統計担当者と効果的にコミュニケーションできる英語の口頭および書面による能力
Pfizerは均等な雇用機会を提供する企業であり、事業を展開する各法域の適用される均等雇用機会法を遵守する。
Job Summary
Design, analyze, and interpret clinical trials/post marketing surveillance (PMS) in compliance with relevant regulatory requirements, company standards and best practices
Provide scientifically rigorous statistical expertise and contributions by working effectively within the clinical triad (clinician, clinical pharmacologist, and statistician)
JOB RESPONSIBILITIES
- Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.
- Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.
- Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
- Develop effective collaborations with others within clinical teams, partner lines, and external regulatory, industry, professional and academic organizations.
- Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and company standards.
- Be up-to-date on SOP training and compliance with all SOPs as required based on the assigned curriculum.
- Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, Data managers (i.e., Clinical Data Scientist), Clinical Programming colleagues (i.e., Statistical Data Sciences Lead) – for assigned studies/PMS and regulatory submissions.
- Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
- Comply with all statistics and quality processes and company's data standards that are applicable to statistical outputs, and support processes that require statistical input.
- Communicate and collaborate with global Therapeutic Area (TA) statisticianson assigned projects.
- Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
- Participate in research on statistical methodology and its applications to clinical trials/PMS.
QUALIFICATIONS / SKILLS
Behavioral Skills:
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
Consulting skills
Capability to provide statistical leadership to cross-functional teams
Technical skills:
Strong statistical/epidemiological skills with application to clinical trials/PMS
A broad understanding of drug development
Knowledge of clinical medicine and regulatory requirements
Education/Certification:
Advanced degree in statistics, biostatistics, or related field
Languages:
Written and oral communication skills in English to effectively communicate with TA statisticians
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
MedicalBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)