资深统计学家/咨询团队统计经理
Principal Statistician/Manager Statistics for Consultancy Team
职位空缺：全职统计顾问加入Veramed统计咨询业务单元。该职位将为各类客户提供统计支持。
统计咨询业务单元通常与小型及成长型生物科技和制药公司合作，参与临床开发生命周期中的各类项目。我们可提供的统计咨询支持领域包括研究设计与试验规划、方案制定、监管统计支持、研究实施与监督以及其他临时性统计支持。
职责可能包括：研究设计，包括样本量计算、模拟和自适应设计；协助监管提交的统计方面并回应监管问题；项目层面的统计输入；研究的统计监督；审查和监督其他CRO的交付成果；制定和/或审查研究文件，包括方案和统计分析计划的统计部分；临时性和探索性分析；根据需要提供其他统计支持。成功候选人需参加与潜在客户的会议以赢得工作。
此职位适合至少有10年经验的人士，能够与没有或仅有有限内部统计支持的客户合作，有与临床医生和其他学科密切合作的经验，并有提供统计咨询建议的先前经验。能够向非统计人员解释统计概念至关重要，同时具备向客户团队进行展示的能力，并能清晰简洁地表达复杂想法。
虽然在需要时会从Veramed获得支持，但您需要能够独立工作，管理自己的工作量，并同时处理多个客户的多个项目。此外，还将有机会支持和培养更初级的团队成员并监督他们的工作，因此具备有效分配任务的能力至关重要。
以下专业领域知识将有益但非必需：
- 研究设计/样本量经验，模拟，自适应设计
- 监管经验，特别是与FDA的互动
- 贝叶斯方法
- 熟练使用SAS或R进行编程
- 快速掌握项目要求并研究新的治疗领域（TAs）的能力
查看英文原文
An opportunity has arisen for a Statistician to join Veramed’s Statistical Consultancy Business Unit full time. The opportunity will be to provide statistical support to a variety of clients.
The Statistical Consultancy Business Unit typically works with small and growing Biotech and Pharmaceutical companies on a variety of projects across the full clinical development lifecycle. The areas in which we can provide statistical consultancy support include study planning and trial design, protocol development, regulatory statistical support, study conduct and oversight and other ad-hoc statistical support.
Responsibilities may include: study design, including sample size calculations, simulations and adaptive designs; support with the statistical aspects of regulatory submissions and responding to regulatory queries; project level statistical input; study statistical oversight; review and oversight of deliverables from other CROs; development and/or review of study documentation including the statistical aspects of protocols and statistical analysis plans; ad-hoc and exploratory analyses; other statistical support as required. The successful candidate would be expected to attend meetings with prospective clients in order to win work.
This role would be suitable for someone with at least 10 years’ experience, who is comfortable working on projects with clients who have no or limited internal statistical support, has experience working closely with clinicians and other disciplines and has prior experience providing statistical consultancy advice. The ability to explain statistical concepts to non-statisticians is essential as well as being comfortable presenting to client teams and the ability to present complex ideas in a clear, concise way.
Whilst you will have support from within Veramed as needed, you will need to be comfortable working independently, managing your own workload and working on multiple projects for multiple clients. There will also be an opportunity to support and develop more junior team members and to oversee their work, so an ability to effectively delegate where appropriate is essential.
The following areas of expertise would be beneficial but not essential:
- Study design/sample size experience, simulations, adaptive designs
- Regulatory experience, particularly FDA interactions
- Bayesian methods
- Confident programming in either SAS or R
- Ability to quickly get up to speed with the project requirements and research new TAs or statistical methods as needed
**_Veramed is a B Corp_** _accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability._
_As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment._