生物统计学总监
Director, Biostatistics
向生物统计与数据管理副总裁汇报，生物统计总监将专注于在多个研究中积极贡献，分析并报告临床研究的任何或所有部分。该职位将负责统计编程和交付成果的监督，以确保统计分析的质量保证和控制，撰写正式报告中的方法和分析描述，与合作者沟通，并组织和维护机密项目资料。
职责：
- 领导和协调与统计相关的活动，以支持临床研究，包括但不限于支持研究设计、执行、分析、解释和报告，以及数据证据的沟通。
- 支持业务关键和/或监管承诺的统计方面，为项目计划提供输入，并代表生物统计部门参与跨职能和部门内团队或工作组。
- 根据需要准备或审查临床研究方案、病例报告表、统计分析计划和表格模板。
- 创建或验证用于数据管理活动、符合要求的分析数据集和临床试验数据统计分析的SAS程序。
- 准备临床试验报告的统计部分，并向团队展示结果。
- 展示对监管指南和统计方法在药物开发中的临床研究应用的深入理解。
- 在最少指导的情况下撰写统计报告和备忘录。
- 验证复杂的数据集或汇总表格。
- 监督CRO的统计交付成果
- 其他指派的任务。
资格：
- 统计学、生物统计学或相关领域的硕士学位；博士优先。
- 至少7年临床试验经验，其中至少2年在肿瘤临床试验领域。
- 有实体瘤肿瘤学和全球NDA/BLA提交经验者优先。
- 作为主要统计学家，有设计、执行和报告III期肿瘤临床试验的经验者优先。
- 精通统计软件包，包括SAS和R。熟悉其他统计分析和报告应用程序如Splus和SQL者优先。
- 能够清晰地写作和表达。
- 具有强烈的时间紧迫感和对实现既定项目目标的卓越承诺。
- 能够优先处理任务。
查看英文原文
Reporting to the Vice President, Biostatistics and Data Management, the Director, Biostatistics will focus on actively contributing to efforts across multiple studies, analyzing and reporting on any or all parts of clinical studies. The role will have oversight of statistical programming and deliverables that contribute to the quality assurance and control of statistical analyses, writing methods and analysis descriptions in formal reports, communicating with collaborators, and organizing and maintaining confidential project materials.
Responsibilities:
- Lead and coordinate statistical related activities to support clinical studies including but not limited to supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence.
- Support for the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represents the Biostatistics function for cross-functional and intra-departmental teams or working groups.
- Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed.
- Create or validate SAS programs for data management activities, 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.
- Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development.
- Writing statistical reports and memos with minimal guidance.
- Validating complex datasets or summary tables.
- Oversight CRO on statistical deliverables
- Other duties as assigned.
Qualifications:
- Master's Degree in statistics, biostatistics or a closely related field; PhD preferred.
- 7+ years clinical trials experience with at least 2 years in oncology clinical trials.
- Experience with solid tumor oncology and global NDA/BLA submissions preferred.
- Experience with design, execution, and reporting phase 3 oncology clinical trials as a lead statistician preferred.
- Strong knowledge of statistical software packages including SAS and R. Other statistical analysis and reporting applications such as Splus and SQL are plus.
- Ability to write and articulate clearly.
- Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives.
- Ability to prioritize workload to meet multiple delivery timelines.
- Excellent planning and organization skills.
- Excellent problem-solving abilities.
- Ability to function independently and exercise judgment and decision-making skills.
- Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
- Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
- Maintain a positive, approachable and professional attitude.
About Celcuity:
Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.
The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.
Celcuity is an Equal-Opportunity Employer.
Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $195,000 to $215,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.
Originally posted on Himalayas