Position: Statistics Senior manager/Associate director

Department: Clinical development

Report to: Senior director of Medical Science

Location: Shanghai

About Connect Biopharmaceuticals

Connect Biopharmaceuticals is a China-based global clinical-stage company focused on discovery and development of novel immune modulators for the treatment of autoimmune diseases and inflammation.

Job introduction

Statistics head provide statistical expertise to the design and interpretation of clinical studies and programmes.

Major responsibilities

• Application of statistical skills and thinking to develop design options that address cost time uncertainty and probability of success with the appropriate use of modelling and simulation or other techniques to enable the business to make informed decisions.
• Providing specifications and direction to outsourcing partners/providers to ensure clarity and appropriateness of specifications and standards, early resolution of emerging issues. They hold partners and providers accountable for the quality of their deliverable.
• Internal delivery of statistical analysis plan, statistical analysis report, or statistical analysis wherever as needed.
• Application of statistical skills to provide support to the regulatory submissions including specification of overview documents and response to regulatory questions.
• Contributing to the development, sharing and/or statistical support of new procedures, tools or techniques in order that the quality, efficiency or effectiveness of the Group is improved.
• Identifies and applies statistical methodology to improve the methodology and provide practical solutions for clinical development activities
• Network with colleagues and experts, providing statistical expertise and serving as a resource for others by sharing experience within and beyond project team.

Qualifications

• MS/MSc in Statistics, Medical Statistics or related field with at least 8-years’ experience as a statistician in the health care environment or relevant areas of statistical applications
• Application of statistical techniques in the analysis of data from clinical studies or other relevant areas
• Ability to communicate statistical concepts to non-statisticians both verbally and in writing
• Ability to influence others in a team environment.
• Presentation of statistical methods and results to a variety of audiences especially non-statisticians.
• Proficiency in computer skills
• Availability to travel

Prefer:

• PhD in Statistics with experience as a statistician in the health care environment or relevant areas of statistical applications
• Experience of study design from more than one phases of drug development
• Experience of regulatory submissions and commercial support.
• Knowledge of Pharmaceutical drug development and marketing

职位: 统计高级经理/副总监

部门: 临床开发

汇报上级: 高级医学总监

工作地点: 上海

公司简介

康乃德生物医药是立足于中国的，具有全球权益临床阶段产品的新药创新公司。康乃德专注于发现和开发新型免疫调节制剂，治疗自身免疫性疾病和炎症。

职位介绍

统计高级经理/付总监为临床试验和方案的设计和解释提供统计专业知识。

主要职责

• 运用统计技巧和思维开发设计选项，通过适当使用建模和模拟或其他技术来解决成本时间不确定性和成功概率，从而使企业能够做出明智的决策。
• 为外部合作伙伴/供应商提供规格和方向，以确保规格和标准的清晰性和适宜性，及早解决新出现的问题。让合作伙伴和供应商对其交付品质量负责。
• 根据需要在内部提供统计分析计划，统计分析报告或统计分析。
• 应用统计技能为监管递交提供支持，包括概述文件的说明和对监管问题的回应。
• 促进新程序，工具或技术的开发，分享和/或统计支持，以提高团队的质量，效率或有效性。
• 确定并应用统计方法学，改进方法论，并为临床开发活动提供切实可行的解决方案。
• 联系同事和专家，提供统计专业知识，并能通过分享项目团队内外的经验，为他人提供资源。

任职要求

• 统计学，医学统计学或相关领域的MS / MSc学位，或者至少8年在统计学应用的卫生保健环境或相关领域的统计学家的经验
• 能够应用统计技术分析临床研究或其他相关领域的数据
• 能够以口头和书面形式向非统计人员传达统计概念
• 能够在团队中影响他人
• 向各种受众特别是非统计人员介绍统计方法和结果
• 熟练掌握电脑技能
• 可适应出差

加分项：

• 具有统计学博士学位，担任统计学家在卫生保健环境或相关统计应用领域的经验
• 具有从多个药物开发阶段进行研究设计的经验
• 具有监管提交和商业支持的经验
• 具有药物开发和市场营销知识

上班地址：soho广场