Head of Biometrics, Clin-nov Medical Global(J10959)

职位描述

Report to:

US Head, Clin-nov Medical

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

任职要求

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.