上海招聘

POSITION OBJECTIVE:

This position functions as a technical and operational leader interfacing with clients and leading internal statistical and programming teams to achieve clinical development project/program objectives. The accountabilities of this position are described below.

ACCOUNTABILITIES:

1. Work with an Associate Director/Director and/or Senior Director of Statistical Operations to manage clinical trial programs/projects from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs/projects.

2. Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis and reporting.

3. Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects.

4. Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.

5. Serve as a primary biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.

6. Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan.

7. Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others.

8. Perform hands on statistical analysis and modeling, and maintains expertise in state-of-the-art statistical methodology and regulatory requirements.

9. Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall Quality Control review on statistical deliverables before they are released to the clients.

10. Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.

11. Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.

12. Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.

13. Interact with regulatory agencies and support sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirement/expectation (e.g. CDISC).

14. Perform statistical and programming resource management, capacity analysis, benchmarking and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.

15. Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

The weight for each of the above accountabilities/duties will depend on the business needs and the size of the statistical and programming teams that the incumbent will manage. When the size is small, more weight will be put on hands-on program/project management and statistical work; when the size is bigger, more weight will be put on supervisory, management, and business development work.

MINIMUM HIRING REQUIREMENTS:

A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years relevant experience or a Master’s degree in these fields with at least 10 years relevant experience, with demonstrated exceptional ability and performance. Significant contribution, outstanding and sustained performance may be used in lieu of the requirement on the number of years of relevant experience.

爱巍斯医药科技（上海）有限公司 ("Everest ")是一个提供全方位服务的合同研究组织(CRO)，为全球制药、生物技术和医疗器械行业提供广泛专业的临床研究服务。如今，我们已经成功和一些知名客户建立了战略合作关系，在先进药物，生物制剂…..领域都有合作。

Everest创立于2004年，拥有坚实的数据统计和数据管理基础。在此基础上，Everest成功地发展成一个全方位服务的CRO。Everest总部位于加拿大马卡姆市(多伦多地区)，分部位于美国新泽西州小瀑布市(纽约地区)和中国上海市(浦东张江新区)。Everest以其高质量的交付成果、优质的客户服务和灵活的客户满足而业界闻名。作为一个具有创业精神充满活力的组织，Everest取得了凡的成长和巨大的成功。

质量是我们的支柱，客户导向是我们的传统，灵活是我们的力量。这就是我们，是Everest。

为了在临床研究这个领域继续取得成功，我们正在寻找有责任感、有技能、以及客户导向的你一起加入我们。你将为中国和全球的医药研究献力！