生物统计学家
Biostatistician
我们寻找有目标感、充满热情的个人加入我们的团队。从临床到商业再到支持职能,Lexitans相信共同的使命:成为最优秀的眼科产品开发组织,与之合作。
简介
负责临床试验数据的设计、收集、分析、报告、解释和发表
职责
- 保持对生物统计方法、监管趋势和眼科领域行业和学术发展的基本了解
- 支持生物统计学领域新创新、标准、流程和效率的开发与实施
- 提供科学和技术咨询,与内部和外部利益相关者协作,促进对统计服务和产品的理解。支持与数据管理的协作
- 审核临床试验数据并验证关键终点或数据集
- 代表Lexitas与客户和供应商进行沟通
- 确保符合标准和部门SOP,保持一致性
- 确保所有交付物的统计完整性,并撰写方案、统计分析计划、CSRs、演示文稿和临床试验数据出版物的相关部分
要求
教育背景:
- 必须:生物统计学、统计学或相关领域的学士学位或同等学历
- 优先:生物统计学、统计学或相关领域的硕士学位或同等学历
经验:
1年以上在临床研究中的统计分析经验,优先考虑
技能:
- 对药物和医疗产品开发中的统计主题和方法有基本理解
- 优秀的技术和编程逻辑能力
- 具有跨职能协作经验
- 优秀的口头和书面沟通能力
- 良好的计划和组织能力,能够适应并调整以应对不断变化的优先事项
- 能够在动态、快节奏的环境中高效工作,处理多项任务以满足截止日期
- 对发展眼科专业知识有浓厚兴趣
身体要求
该职位需要:具备足够的普通行走能力和身体协调性,以根据需要移动至会议或会议室地点;能够站立、行走、弯腰、跪下、蹲下较长时间;能够搬运轻到中等重量(10-35磅)的物品;手臂、手和手指的灵活性,包括操作能力
查看英文原文
We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with.
Overview
Inform the design, collection, analysis, reporting, interpretation, and publication of clinical trial data
Responsibilities
- Maintains a basic understanding of industry and academic developments in biostatistical methodology, regulatory trends, and ophthalmology
- Supports the development and rollout of new innovations, standards, processes, and efficiencies within Biostatistics
- Provides scientific and technical consultation and collaborates with internal and external stakeholders to facilitate understanding of statistical services and product. Supports collaboration with Data Management.
- Reviews clinical trial data and validates key endpoints or datasets
- Represents Lexitas in interfaces with Sponsors and vendors
- Ensures consistency and adherence to standards and departmental SOPs
- Ensures the statistical integrity of all deliverables and authors appropriate sections of protocols, statistical analysis plans, CSRs, presentations, and publications of clinical trial data
Requirements
Education:
- Required: Bachelor’s degree or international equivalent in Biostatistics, Statistics, or related field
- Preferred: Master’s degree or equivalent in Biostatistics, Statistics, or related field.
Experience:
1 or more years of experience in statistical analysis within clinical research, preferred
Skills:
- Basic understanding of statistical topics and methodology in drug and medical product development
- Excellent technical and programming logic skills
- Experience with cross-functional collaboration
- Excellent verbal and written communication skills
- Good planning and organizational skills with the ability to adapt and adjust to changing priorities
- Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment
- Strong interest in developing expertise in ophthalmology
Physical Requirements
Position requires: ordinary ambulatory skills and physical coordination sufficient to move aboutconference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Originally posted on Himalayas