Head of Biometrics

面议

海外国家

刷新时间：2023-12-06

职位描述

Responsibilities:

●Build, lead, motivate and drive the performance of biometrics US team to achieve agreed objectives, plan and manage resources needs

●As a member of Clin-nov US leadership team and DM&Stats functional leadership team, contribute to the regional and functional goals, marketing strategy and business development activities

●Oversee and provide statistical input and guidance related to clinical development from strategic planning to study design, interim analysis and reporting in collaboration with related functions within Clin-nov or external partners and clients

●Participate in regulatory interactions including document authorship, answering requests and meetings at project level, etc.

●Collaborate with cross functional peers to facilitate and optimize the clinical development and registration process

●Actively support business development efforts and contributes to the generation of new business for clinical development solutions through participation in capability presentations, bid defense meetings and other client meetings

●Maintain and update biometrics related SOPs/WIs and best practice based on regulation, healthy authority guidelines and industry practices; ensure that biometrics activities comply with CDISC, health authority regulation, ICH/GCP guidelines and company SOPs/WIs; develop local specific SOPs as appropriate

●Lead or participate industry effort in regulatory guidances, consortium and conferences on behalf of Clin-nov

Job Requirements:

●PhD or MS in Statistics or related discipline.

●At least 10 years of relevant experience in biotechnology or pharmaceutical industry.

●In-depth knowledge of statistical analysis methodologies, experimental design.

●Excellent knowledge of biometrics functions, including biostatistics, SAS programming and data management.

●Solid understanding of regulatory requirements and clinical trial expertise from phase I to Ⅳ studies.

●Excellent knowledge of the international pharmaceutical market and operational support to achieve business success.

●Excellent oral and written communication skills and strong leadership in a team environment.

其他要求

招聘人数：1人
职能类别：临床生物统计

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。