Biostatistician II
我们是谁？收获综合研究组织 (HiRO) 是一个全球性导向，创新性的临床研究组织 (CRO).通过全球运营和集成能力，HiRO 为客户提供了全系列跨境解决方案和服务，包括早期临床前战略规划，临床试验设计，监管事务，药物警，统计，数据管理，端到端项目管理以及临床和医疗监测服务。作为一个新兴的全球 CRO,HiRO 致力于成为市场领先的综合全球临床研究组织，与生物技术和制药公司合作将新的产品从实验室推出到市场，为世界各地患者提供更有效的解决方案。THE ROLE 我们目前正在寻找热情和有才华的生物统计师 II,愿意参与所有活动范围。这个角色与内部部门兼职。该角色是基于罗马尼亚的。关键责任 · 代表和/或与主要生物统计师和 HiRO 客户合作制作分析和报告成果。· 为全球 I-IV 阶段试验提供 ADaM 数据集的研究规范，以及对 ADaM 的统计编程和 QC 进行生产。· 对全球 I- IV 阶段试题表格，列表和数字的统计计划和 QC; ·良好的 SAS 编程技能。· 能够在最小监督下担任项目团队成员的所有职责。· 在一个或多个计算机系统/编程语言/软件包中理想学习计算机知识，除了 SAS 外。·强大的口头和书面沟通能力 （包括向非统计学家传达统计概念和信息的能力）. ·对医学术语，临床试验方法，药物开发过程以及 ICH/GCP 的良好理解 （特别是与统计方法相关）. · 对临床试题基础上的统计原则的良好认识和熟悉 CDISC 要求。· 组织/时间管理能力良好。我们提供的：· 导师和培训人员
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Who we are?
Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO). With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services. As an emerging global CRO, HiRO strives to become a market-leading, integrated global clinical research organization that works collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.
THE ROLE
We are currently looking for an enthusiastic and talented Biostatistician II, willing to be involved in all spectrums of activities. This role works cross-functionally with internal departments.
This role is home-based in Romania.
Key responsibilities
- Production of analysis and reporting deliverables (including statistical analysis plans) on behalf of and/or in conjunction with the Lead Biostatistician and HiRO clients.
- Creation and QC of study specifications for ADaM datasets, and statistical programming and QC of ADaM datasets for global Phase I-IV trials.
- Statistical programming and QC of tables, listings and figures for global Phase I-IV trial
Qualifications and attributes
- Minimum of a Masters (M.Sc.) or equivalent in Medical Statistics or minimum of a degree (or equivalent) in Statistics/Mathematics.
- Minimum of 2 to 3 years of experience working for a CRO
- Fluent in spoken and written English.
- Good SAS programming skills.
- The ability to perform all duties as a project team member with minimal supervision.
- Computer literacy, ideally in one or more computing systems/programming languages/software packages in addition to SAS.
- Strong oral and written communication skills (including the ability to communicate statistical concepts and information to non-statisticians).
- Good understanding of medical terminology, clinical trial methodology, drug development process and ICH/GCP (especially relating to statistical methodology).
- Good knowledge of statistical principals underlying clinical trials.
- Good awareness of, and familiarity with CDISC requirements.
- Good organizational/time management skills.
What we offer:
- Mentorship and training to develop your skills in the clinical trials industry.
- The chance to be part of an effective, dynamic, friendly, and supportive team.
- Work with new and exciting technologies.
- Development opportunities.
For more information about HiRO Company, please visit our page:
We also encourage you to follow our company page on Linkedin for the most up to date company news and job postings.
Originally posted on Himalayas