生物統計編程師 Statistical Programmer

• 在臨床試驗執行期間，領導和協調統計相關活動。 • 參與試驗隨機開展。 • 根據需要準備或審查臨床研究方案、病例報告表、統計分析計劃和模版。 • 為數據管理活動、符合 CDISC 標準的分析數據集和臨床試驗數據的統計分析創建 SAS 程序。 • 準備臨床試驗報告的統計項目，並向團隊介紹結果。 • 在項目團隊中指導和培養經驗不足的統計學家。 • 擁有並提供對於臨床試驗研究的相關法規和統計方法的理解能力。 • 識別、評估和實施創新的統計方法，為客戶產品臨床開展過程提供建議 • Lead and coordinate statistical related activities to support clinical studies. • Participate in randomization development. • Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed. • Create SAS programs for data management activities, CDISC compliant analysis datasets, and statistical analysis of the clinical trial data. • Prepare the statistical section of clinical trial reports and presentations of the results to the team. • Mentor and develop less-experienced statisticians on the project team. • Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical trial development. • Identify, evaluate, and implement innovative statistical methods to provide added value client drug development process