Job Description

工作地点：上海

主要职责：

1 担任临床试验的项目统计师负责人：

a) 积极参与临床试验的研究设计，包括但不限于指定研究目标、终点、统计假设检验策略、样本量/把握度的计算

b) 撰写试验方案的统计部分

c) 撰写统计分析计划（SAP），以及计划在临床研究报告（CSR）、监管文件、出版物中呈现的数据分析结果的表格、图表和列表（TFL）的模板

d) 支持 SAS 代码的开发，以实施预先计划和特需的数据分析，以及准备数据分析结果显示

e) 支持验证编程团队生成的研究数据集和 CSR TFL，以及监管文件和出版物的数据分析结果的正确性；

f) 参与撰写、审阅和定稿注册监管相关的文件，包括但不限于试验方案、SAP、CSR、出版物（摘要、壁报、文章）等

g) 与内部和外部（如 CRO）团队成员合作，协调日常生物统计部门可交付成果的规划和执行

h) 向跨职能团队提供数据分析结果的统计解释和说明

2 确保试验设计和数据收集、处理和分析的统计方法科学合理，能够明确，稳健地达成临床试验和项目的目标。

3 协作并监督外包给 CRO/外部供应商的统计工作，以确保高质量和按时交付

4 对所关注的治疗领域内的疾病、在研产品和监管指导原则有深入的了解

5 在试验设计、数据分析和结果的诠释方面向跨职能项目团队提出建设性的意见和建议

任职要求

教育背景：拥有生物统计学、统计学或相关领域的硕士学位，并具有约 3 年相关工作经验。或者拥有生物统计学、统计学或相关领域的博士学位。

相关经验：

1. 具有设计临床试验和进行数据分析的实操经验；
2. 优先考虑具有与监管机构沟通经验的硕士学位应聘者；
3. 熟悉/具有 SAS、R、EAST 或其他商业或研究分析软件的知识和经验；
4. 具备数据库构架知识。

语言要求：

流利的英语书面和口头沟通能力；

其他技能：需要良好的人际关系和沟通能力。

能力要求

1. 具备学习和应用适配统计方法解决临床试验中的复杂问题的能力，同时注重工作质量
2. 对疾病、治疗领域，在研产品和监管指南的了解，包括药物临床试验质量管理规范（GCP）和国际人用药品注册技术协调会（ICH）指南
3. 能够在跨职能团队中良好协作并高效地工作
4. 良好的沟通技巧和与跨职能团队成员建立良好关系的能力

Responsibilities

• Functions as the lead trial statistician for clinical trials:

1. Contributes to the study design of a clinical trial, including but not limited to specifications of study objectives, endpoints, hypothesis testing strategy, sample size/power calculations
2. Author of the statistical sections of the trial protocol
3. Author of the Statistical Analysis Plan (SAP), as well as the templates of tables, figures and listings (TFLs) to be presented in the Clinical Study Report (CSR), regulatory documents, publications
4. Supports the development of SAS codes to implement the pre-planned and ad hoc data analyses, as well as to prepare data displays
5. Supports the validation of the generated study datasets and CSR TFLs, outputs for regulatory documents and publications
6. Participates in the writing, review and finalization of regulatory documents including but not limited to protocol, SAP, CSR, publications (abstracts, posters, manuscripts), etc.
7. Works collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of day-to-day biostatistics deliverables
8. Provides statistical interpretation and explanation of data analysis results to cross-functional teams

• Ensures study design and statistical methods for data collection, processing and analysis are scientifically sound and can clearly and robustly address the objectives of the clinical trial and program
• Collaborates and oversees statistical works outsourced to CRO/external vendor to ensure high quality and on-time delivery
• Good knowledge of disease, compound and regulatory guidance within the focused therapeutic area
• Provides good-faith challenge to the cross-functional trial team with respect to study design, data analysis and interpretation

Qualifications

• Education: Master degree in Biostatistics, Statistics or an equivalent field with about 3 years relevant work experience, or a Ph.D. degree in Biostatistics, Statistics or an equivalent field
• Experience:

- Experience in designing clinical trials and conducting data analysis;

- Experience of interaction with regulatory authority is preferred for MS level candidate;

- Knowledge of / experience with SAS, R, EAST, or other business or research analytic software;

- Knowledge of data architecture

• Language Requirement: Fluent in both written and verbal English
• Other Skills: Good interpersonal and communication skills

Requirements

• Ability to learn and apply appropriate statistical methods to solve complex problems while also focus on quality of work
• Knowledge of disease, compound and regulatory guidance including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Ability to work collaboratively and efficiently in a cross-functional team
• Good communication skills and ability to build sound relationship with cross-functional team members

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