高级总监，生物统计学
Senior Director, Biostatistics
Immunovant, Inc. 是一家临床阶段的免疫学公司，致力于帮助自身免疫疾病患者实现正常生活。作为抗-FcRn 技术领域的先驱，该公司正在开发创新、靶向的疗法，以满足自身免疫疾病患者复杂且多变的需求。
职位描述：
高级总监，生物统计学将作为 Immunovant 多个研发项目的生物统计学负责人。在此职位上，您将与内部和外部利益相关者合作，执行我们的生物统计学战略。该职位将为您提供参与生物科技初创公司快速发展的独特机会。
主要职责：
- 对分配项目中的统计策略、规划、执行和沟通提供监督和贡献。
- 为临床开发计划、方案制定、统计分析计划、监管提交和问题、统计分析结果的解读以及其他产品支持项目提供科学严谨的统计输入。
- 与其他临床团队成员及合作部门（如医学总监和监管事务）建立有效的合作关系。
- 确保所有研究和项目层面的统计活动符合相关监管要求和 Immunovant 标准。
- 识别利用创新统计方法来优化临床开发流程并促进最佳决策的机会。
- 管理适应症/研究的生物统计学家。
任职要求：
- 统计学、生物统计学、数学或相关领域的博士学位
- 在生物技术、制药或相关健康领域有12年以上经验
- 熟悉相关卫生当局和 ICH 指南以及法规
- 有与卫生当局互动的经验
- 具有从 II 期到上市的药物开发的全面理解
- 有与多样化利益相关者合作的能力
- 强大的书面和口头沟通能力，注重细节
- 渴望在快节奏、创新的环境中工作
- 自然的合作者，享受跨职能团队的工作
工作环境：
- 远程办公
- 动态、互动、快节奏且具有创业精神的环境
- 需要国内或国际出差（少于10%）
薪资范围：
270,000—310,000 美元 USD
薪酬基于
查看英文原文
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
The Role:
The Senior Director, Biostatistics will serve as the Biostatistics lead for several Immunovant’s development programs. In this role, you will be collaborating with both internal and external stakeholders to deliver the tactical execution of our Biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.
Key Responsibilities:
- Provide oversight and contributions to statistics strategy, planning, execution, and communication for programs as assigned.
- Provide scientifically rigorous statistical input into clinical development plans, protocol development, statistical analysis plans, regulatory submissions and questions, interpretation of statistical analysis results, and other product support initiatives.
- Develop effective collaborations with others within clinical teams and partner lines (such as Medical Directors and Regulatory).
- Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards.
- Identify opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making.
- Manage indication/study biostatisticians.
Requirements:
- PhD. in Statistic, Biostatistics, Mathematics or related field
- 12+ years of experience in biotechnology, pharmaceutical or health related area
- Knowledge of relevant Health Authority and ICH guidelines, as well as regulations
- Demonstrated experience in engaging with Health Authorities
- Comprehensive understanding of drug development from Phase 2 to launch
- Demonstrated ability to collaborate with diverse sets of stakeholders
- Strong written and oral communication skills with attention to detail
- Desire to work in a fast-paced, innovative environment
- Natural collaborator who enjoys working on a cross-functional team
Work Environment:
- Remote-based
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (<10%)
Salary range for posting
$270,000—$310,000 USD
Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.
Originally posted on Himalayas