[R&D] Statistician/統計担当者

<p><b>職務概要</b></p><p>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&#xff08;SOP&#xff09;、およびベストプラクティスに従って業務を行う。<br />臨床開発チームの中で特に&#xff08;臨床開発リーダー、臨床薬理担当者、統計担当者&#xff09;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。</p><p></p><p><b>職務内容</b></p><ul><li>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。</li><li>統計解析、解析結果、科学的な報告書&#xff08;主要な統計解析結果の即時報告書、治験総括報告書等&#xff09;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。</li><li>担当プロジェクト&#xff08;担当する医薬品開発&#xff09;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。</li><li>担当プロジェクトにおいて、米国本社の治療領域&#xff08;TA&#xff09;統計担当者とコミュニケーション・協働を行う。</li><li>臨床開発チーム内外の関係者&#xff08;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&#xff09;と効果的な協力関係を構築する。</li><li>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。</li><li>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。</li><li>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。</li><li>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。</li><li>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。</li><li>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。</li></ul><p></p><p><b>必要な資格・スキル</b></p><p><b>行動スキル</b></p><ul><li>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</li><li>コンサルティングスキル</li><li>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</li></ul><p><b>技術スキル</b></p><ul><li>臨床試験への応用に関する高度な統計スキル</li><li>医薬品開発に関する幅広い理解</li><li>臨床医学および規制要件に関する知識</li></ul><p><b>学歴・資格</b></p><ul><li>統計学、生物統計学、または関連分野の学位&#xff08;修士号以上&#xff09;</li></ul><p><b>言語</b></p><ul><li>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</li></ul><p></p><p>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。</p><p></p><p>Job Summary</p><ul><li><p><span><span>Design, </span><span>a</span><span>nalyze, and </span><span>i</span><span>nterpret </span><span>c</span><span>linical </span><span>t</span><span>rials/</span><span>p</span><span>ost </span><span>m</span><span>arketing </span><span>s</span><span>urveillance (PMS) in compliance with relevant regulatory requirements, company </span><span>standards</span><span> and best practices</span></span></p></li></ul><ul><li><p><span><span>Provide scientifically rigorous statistical </span><span>expertise</span><span> and contributions by working effectively within the clinical triad (clinician, clinical pharmacologist, and statistician)</span></span></p></li></ul><p><span>JOB RESPONSIBILITIES</span></p><ul><li><span><span>Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory </span><span>issues</span><span> and scientific and commercialization projects</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports</span><span> (topline reports, clinical study reports, etc.)</span><span>, including clinica</span><span>l trial</span><span>/PMS</span><span> results</span><span>, support for publication activities, scientific presentations, and support to </span><span>responses</span><span> to queries from regulatory </span><span>authority</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Be accountable for study</span><span>/PMS</span><span> level and submission level statistical deliverables on assigned projects</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Develop effective collaborations with others within clinical teams, partner lines, and external regulatory, industry, professional and academic organizations</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Ensure that all study</span><span>/PMS</span><span> and project level statistical activities are conducted in compliance with relevant regulatory requirements and company standards</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Be </span><span>up-to-date</span><span> on SOP training and compliance with all SOPs as </span><span>required</span><span> based on the assigned curriculum</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, </span><span>Data</span><span> managers</span><span> (i.e., Clinical Data Scientist)</span><span>, C</span><span>linical Programming</span><span> colleagues </span><span>(i.e., </span><span>Statistical Data Sciences Lead</span></span><span><span>) </span></span><span><span>– for assigned studies</span><span>/PMS</span><span> and regulatory submissions</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Comply with</span><span> all statistics and quality processes and company&#39;s data standards that </span><span>are applicable</span><span> to statistical outputs, and support processes that require statistical input</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Communicate and collaborate with </span><span>global </span><span>Therapeutic Area (TA)</span><span> statisticians</span></span><span><span> </span></span><span><span>on assigned projects</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice</span></span><span><span>.</span></span></li></ul><ul><li><span><span>Participate in research on statistical </span><span>methodology</span><span> and its applications to </span><span>clinical trials/</span><span>PMS</span></span><span><span>.</span></span></li></ul><p></p><p><span>QUALIFICATIONS / SKILLS</span></p><p><span><span>Behavioral </span><span>S</span><span>kills</span></span><span><span>:</span></span></p><ul><li><p><span><span>Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization</span></span></p></li></ul><ul><li><p><span><span>Consulting skills</span></span></p></li></ul><ul><li><p><span><span>Capability to provide statistical leadership to cross-functional teams</span></span></p></li></ul><p></p><p><span><span>Technical skills</span></span><span><span>:</span></span></p><ul><li><p><span><span>Strong statistical/epidemiological skills with application to clinical trials/PMS</span></span></p></li></ul><ul><li><p><span><span>A broad understanding of drug development</span></span></p></li></ul><ul><li><p><span><span>Knowledge of clinical medicine and regulatory requirements</span></span></p></li></ul><p></p><p><span><span>Education/Certification</span></span><span><span>:</span></span></p><ul><li><p><span><span>Advanced degree in statistics, biostatistics, or related field</span></span></p></li></ul><p></p><p><span><span>Languages</span></span><span><span>:</span></span></p><ul><li><p><span><span>Written and oral communication skills in English to effectively communicate with </span><span>TA</span><span> statisticians</span></span></p></li></ul><p> <br />Work Location Assignment: Hybrid</p><p style="text-align:inherit"></p><p style="text-align:left"><span><span><span><span><span><span><span><span><span>Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</span></span></span></span></span></span></span></span></span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Medical<p></p><p></p>