出海雷达

生物统计学总监

Associate Director, Biostatistics

其他限定地区(需当地身份)
公司BeiGene
薪资$162,600 - $212,600/年
工作地点United States
地域资格限定地区(需当地身份)
时区要求日间重叠约 9 小时,基本正常作息
用工类型Full Time
发布时间15 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 United States 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

BeOne持续以快速的节奏增长,为经验丰富的专业人士提供具有挑战性和令人兴奋的机会。在选择候选人时,我们寻找具有科学和商业背景、高度积极、善于合作,并且最重要的是,与我们一样对抗击癌症充满热情的专业人士。
职位描述:
与跨职能的研究/项目团队合作,支持血液学研究,并与临床、监管、统计编程、数据管理和其他研究科学家互动,审查数据,制定并实施临床研究报告(CSR)及其他监管机构提交文件的统计分析计划(SAP)。为论文/演讲提供内容,并在设计和分析临床试验中提供统计支持,协调临床项目的统计活动。
主要职责与责任:
· 开发或协助开发研究方案和SAP,并确定数据分析的适当统计方法。
· 参与数据库设计会议,确保所评估的数据质量高并满足分析需求。
· 与统计编程人员合作,确保所有程序符合分析要求、内部标准操作规程和外部监管要求。
· 分析临床试验数据并解释结果,以满足研究方案的目标。在监督下应用和实施基本和复杂的分析技术。
· 准备口头和书面报告,有效地向项目团队传达临床试验结果。
· 回应临床监查员、监管机构和/或研究者提出的有关研究设计、分析和解释的问题。
· 参与创新统计方法和在临床试验开发中的应用的研究活动。
计算机技能:熟悉SAS和/或R是强烈建议的
其他资格:需要有临床试验经验和了解监管指南。有肿瘤学经验者优先,但非必需。需要具备良好的书面和口头沟通能力,能够在团队中工作并独立工作。其他重要要求包括相互依赖/分析思维能力、建立战略工作关系以及良好的决策能力。
出差:不需要
教育要求:

查看英文原文

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
Work with cross-functional study/project teams supporting hematology studies and interact with Clinical,
Regulatory, Statistical Programming, Data Management and other Research Scientists in reviewing the data,
developing and implementing the statistical analysis plan (SAP) for the clinical study report (CSR) and other
health authority submission documents. Provides content for manuscripts / presentations and provides
statistical support in designing and analyzing clinical trials, and in coordinating the statistical activities for
clinical projects.
Essential Duties & Responsibilities:
· Develops or assists development of study protocols and SAPs and determines appropriate statistical

methodology for data analysis.
· Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy

analysis requirements.
· Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements,

internal standard operating procedures, and external regulatory requirements.
· Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Applies and

implements basic and complex techniques to these analyses under supervision.

  • Prepares oral and written reports to effectively communicate results of clinical trials to the project team.
  • Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical

monitors, regulatory agencies, and/or investigators.
· Involved in research activities for innovative statistical methods and applications in clinical trial

development.
Computer Skills: Knowledge of SAS and/or R is strongly desirable
Other Qualifications: Experiences with clinical trials and knowledge of regulatory guidance are
required. Oncology experience is preferred but not required. Demonstrated written and oral
communication skills and ability to work within a team and work independently are required. Other
important requirements include interdependent/analytic thinking skills, building strategic working
relationships, and good decision-making capability.
Travel: Not required
Education Required:
A minimum of a PhD in Statistics or related field with 5+ years of experience, or a Master’s degree with a minimum of 8 years of experience in clinical drug development is required.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

Salary Range: $162,600.00 - $212,600.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .
Originally posted on Himalayas

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