Principal Statistician - UK/Europe
职位标题：主要统计师 - 英国/欧洲 （远程）工作地点：虚拟英国工作场所类型：远程工作合同类型：全日制工作资深级别：我们是什么？我们是一个全球的中大型 CRO,跨越界限，创新和发明，因为世界上最持久的疾病的治疗路由那些认为安全的人没有铺平。它是由那些采取先，创造性方法并以质量和卓越的方式实施者构建的。我们是世界范围内的临床试验，我们是一支拥有超过3,500+专家，思想家，梦想家和行为者的全球明亮团队，共同改变了全世界最佳方式体验 CROs. 我们的使命是每天以热情和目的努力改善生活，我们正在寻找那些重视同样的追求的人。为什么全球 我们相信每个人都在为患者及其护理人员带来变化方面发挥重要作用。从我们的实践可靠领导者到我们的团队，我们致力于让来自不同背景和经验的专业人士取得成功。我们优先培养多元化的包容环境，继续促进合作和创造力。我们自豪地成为一个通过自我发展而成长并受到鼓舞的工作场所。加入我们！作为我们生物统计和统计编程团队的个人，你的编程，分析技能以及处理和解释数据的能力是成功的关键。在全球，你将能够在临床试验的所有阶段都提高 SAS 和 CDISC 标准的知识。你将直接与多个赞助商，数据管理人员，统计学家，统计程序员以及更广泛的研究小组合作，包括心血管，代谢，神经科学，肿肿瘤学和罕见疾病等各种治疗领域。在这里工作时，你有自主性通过实践参与完成你的工作，获得成功和成长所需的支持以及意识到在这里你的工作确实重要。你将做什么？·提供研究设计，分析计划和报告的审查。贡献临床试验的设计，包括研究协议的统计部分，随机化方法及编写统计分析计划。能够了解和建议研究设计和分析核心组成部分。·提供对统计报告的支持。
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Job Title: Principal Statistician - UK/Europe (Remote)
Job Location: Virtual United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Biostatistics Department does at Worldwide
As an individual on our Biostats and Statistical Programming team, your programming, analytical skills, and ability to process and interpret data are the keys to success. At Worldwide, you’ll be able to grow your knowledge of SAS and CDISC standards across all phases of clinical trials. You’ll work directly with multiple sponsors, data managers, statisticians, statistical programmers, and the wider study team across a variety of therapeutic areas including cardiovascular, metabolic, neuroscience, oncology & rare diseases. When you work here, you have the autonomy to do your work through hands-on involvement, the support you need to succeed and grow, and the realization that, here, your work really does matter.
What you will do
- Provide review of study designs, analysis plans, andreports.Contributeto the design of clinical trials, including statistical sections of the study protocol, randomizationmethodologyand writing Statistical Analysis Plans. Able to understand and advise on core components of study design and analysis.
- Provide support to the statistics reporting process through the specification/review of tables, figures, and listing shells, writing/review of derived dataset specifications, and the formatting of report documents and tabulations.
- Undertake and/or contribute to the preparation of final reports, including production of tables, figures, and listings and report writing.
- Develop, test, and run SAS programs for the statistical analysis of clinical study data. This includes programs for derived datasets, SDTM/ADaM datasets, tables, figures, and listings, and/or associated validation.
- Contribute to the identification of system and process improvements, and to the development and implementation of solutions to improve the efficiency and quality of clinical study data processing and reporting.
- Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are fully met by expert andtimelystatistical consultancy and support
- Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant ICH standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).
- Liaise with internal departments, sponsors, and other third partiesregardingstatistical issues and reporting requirements
- Apply department knowledge of the latest developments in statistical methods, regulations (in particular ICH, FDA, CPMP points to consider efficacy,safetyand quality standards) and software applications
- Review budgets and flag any out of scope or unbudgeted items,identifyany tasks not in alignment with current scope of work.
What you will bring to the role
- Must be computer literate and numerate with a proven ability to adapt to various computer systems; thorough knowledge of SAS; knowledge of other software applications a plus
- Consultancy and facilitation skills arerequiredtogether with key competencies in customer focus, delivering on commitments, building strong relationships, communicating, and influencing, embracing innovation and change.
Your experience
- Appropriate degree and minimum relevant experience: (BSc/8 years, MSc/6 years, PhD/4 years)
- Hands-onexpert levelproject statistician experienced in providing statistical leadership to projects.
- Experienced in a broad range of statistical applications across all phases of clinical research with a thorough knowledge of regulatory standards and exposure to regulatory interactions.
- Good oral and written communication, organizationalskillsand personal presentation. The ability to communicate effectively in English
- Ability to prioritize and handle multiple projects simultaneously, a flexible approach, the ability to use sound independent judgement and take initiative to assess information.
- Experience acrossmultiple therapeutic areas
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
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Originally posted on Himalayas