[Japan] 統計解析マネージャー
Descrizione dell'offerta
To keep abreast of and analyze innovative statistical methods and various statistical issues in clinical trials, as well as the latest developments in regulatory authorities and industry, and to reflect them in clinical trial planning and practice as necessary. Participate in the study planning process from an early stage to develop scientifically appropriate study designs and protocols, and to ensure and improve the quality of clinical trials. Lead and conduct clinical trials and exploratory clinical research from statistical point of view, ensuring scientifically sound interpretation of clinical trials and exploratory clinical research and appropriate application of statistical methodologies. Lead the discussion related study design, statistical methodologies including “Estimand Framework” and interpretation of study results for Ph2b/Ph3 with authority (PMDA) Communicate effectively with stakeholders about clinical trial plans or results, both orally and in writing. Understand global and cross-cultural diversity, communicate in English, and contribute to international development work. Acquire knowledge and skills to improve work processes, etc. Chance to have collaboration with AI related activities in data science. 臨床試験における革新的な統計手法や各種統計課題、ならびに規制当局および業界動向の最新情報を継続的に収集・分析し、必要に応じて臨床試験の計画および実施に反映する。 開発初期段階から試験計画プロセスに参画し、科学的に適切な試験デザインおよび試験実施計画書（プロトコル）の策定を推進するとともに、臨床試験の品質確保および向上に貢献する。 統計学的観点から臨床試験および探索的臨床研究（トランスレーショナルリサーチ）を主導し、科学的に妥当な結果解釈と適切な統計手法の適用を確保する。 第Ⅱb相試験および第Ⅲ相試験において、試験デザイン、Estimand Frameworkを含む統計的方法論、ならびに試験結果の解釈に関する規制当局（PMDA等）との協議を主導する。 臨床試験の計画および結果について、社内外の関係者に対し、口頭および文書により効果的にコミュニケーションを行う。 グローバルかつ多様な文化的背景を理解し、英語を用いたコミュニケーションを通じて国際開発業務に貢献する。 業務プロセスの改善等に必要な知識およびスキルの習得・向上に努める。 データサイエンス分野におけるAI関連活動との連携・協働に参画する機会を有する。 Master's degree in science or equivalent preferred. At least 5 years of work experience as a Statistician in the pharmaceutical industry. SAS code skill is mandatory, and R/Python skills are preferred. Self-motivated with a desire to continually impr
Dettagli
- Azienda: Santen
- Sede: Remoto
- Tipo di contratto: Tempo pieno
- Fonte: smartrecruiters
- Valido fino al: 22 novembre 2026
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