天津招聘

Position Summary:
Frontage is seeking a mature and enthusiastic director level Biostatistician to join our Biometric operation in China.

Reporting to Global Head of Biometrics, incumbent, as Site Head of Biometrics has the overall managerial and technical responsibilities for China operations including CDM, Biostatistics and Statistical Programming.

Major Responsibilities:
China Site Head and Director of Biometric is responsible for managing a biometric team and brings statistical expertise to the design, conduct, analysis and reporting of clinical studies, in the pre-clinical, phases I to IV, and post-marketing stages of study. Duties include, but are not limited to:
1. Manages statisticians, Data Management staff and statistical programmers to support global and Chinese clinical studies. Manages timelines, work allocation and project tracking.
2. Applies statistical theory and methods to the design and analysis of clinical trial data; prepares data analysis plans, assists with the preparation of manuscripts and writes reports describing results of statistical analysis; presents results as requested in the form of text, tables, tabulations, and graphs.
3. Provides statistical support and consultation to management for grant and request for proposal preparations, as well as study protocols; serves as project biostatistician/representative to sponsors regarding study design.
4. Reviews study protocols in development to ensure that the study case report forms and database can adequately capture data needed for the SAP.
5. Provide expertise in leading, coaching and training to biometric staff.
6. Provide senior review on the deliverables produced by biometric team.
7. Responsible for the development and review of corrective action plans as requested on audits and implements plans as required.
8. Manages biometric team to conduct all work within the context of Good Clinical Practice (GCP) and according to company SOPs and guidelines.

Qualifications:
1. PhD in Statistics or Biostatistics preferred. MS will be considered only with proven records.
2. Minimum of 35 years' experience in clinical trials in a pharmaceutical or contract research organization environment.
3. Proficiency in SAS programming skills in performing statistical analyses and reporting.
4. Experience in providing statistical support in broad range of therapeutic areas desirable.
5. Strong understanding of the clinical trial process from data acquisition to data reporting.
6. Prior experience of managing a mid-size biometric team desirable (2-3 years).
7. Ability to lead, coach, influence technically and effectively a highly technical staff.
8. Must possess excellent communication and writing skills, ability to multi-task and set priorities, excellent organizational planning, project management and time management skills.

方达医药全球型全方位新药研发外包服务公司（CRO）,于2001年成立于美国，总部位于宾夕法尼亚州费城西郊的埃克斯顿。2006年成立方达医药技术（上海）有限公司，在苏州和郑州分别设有分公司和管理团队。2019年5月30日，方达控股（方达医药上市主体）成功登陆香港联交所主板，股票代码*******。

方达医药始终坚持“中美两国，同一质量体系”准则，获得数据可用于全球申报，目前已为全球400多家客户提供高质量、高标准的新药和仿制药研发服务。作为中国制药企业国际化及高端药物研发合作伙伴，方达医药拥有技术熟练的专业团队，配备了国际最先进的药物研发仪器和设备，并努力为客户创造友好轻松的合作和沟通环境。专注于一体化的专业服务，业务范围包括生物分析、BE临床服务、CMC药品制剂研发、cGMP咨询及国际药品注册等服务项目。

● 我们为员工提供全面的福利待遇，并履行对员工健康和福利的全面承诺。
● 我们为员工提供了与***制药公司合作的机会，让其成为药物开发过程的关键贡献者。
● 我们为员工提供良好的职业发展机会，确保员工在行业内不断积累经验。
● 我们的员工是最有价值的资产，我们拥有明确的员工奖赏计划，肯定员工的奉献精神，奖励员工的辛勤付出。

您也可以发送简历至招聘邮箱：recruitment@frontagelab.com.cn
更多信息请浏览公司网站：**********************