上海招聘

POSITION OBJECTIVE:

This position is accountable for developing, applying and/or providing expertise in statistical and data management methods and techniques to effectively enable decision making in support of the company’s mission, strategies, customers and priorities. In addition to the technical accountabilities, this position assumes project management responsibilities in directing and managing statistical and data management team activities for clinical trials from the development of study protocols to the completion of study reports.

May represent division and the company, participate in business development and customer relationship management activities, and provide leadership in executing divisional and corporate plans.

ACCOUNTABILITIES:

1. Provide leadership/expertise in resolving complex problems in support of divisional/company objectives, or assigned projects, or as a consultant to others. May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but are not limited to, the following:

· Providing leadership/expertise in research and development of statistical methodologies.

· Investigating and implementing new technologies, processes and procedures.

· Developing and executing marketing strategies and plans (trade shows, publications/presentations, corporate website design and maintenance, meeting with existing and new clients).

· Developing and executing customer relationship management plans.

· Participating in new business development and bidding processes.

2. Perform review for clinical study protocols and statistical/data management documents generated by others.

3. Act as Lead Biostatistician/Liaison Biostatistician to interact with clinical trial sponsor companies, and oversee projects for a sponsor company and/or for given therapeutic areas.

4. Lead assigned projects by applying project management skills, statistical and data management techniques to facilitate better decision making, improve business operations and discover, improve, develop or defend new or existing products.

5. Plan, develop and monitor timelines for statistical and data management activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and data management resource needs and manage the assigned resources.

6. Provide statistical and data management input into protocol development. Write Statistical Analysis Plans for assigned projects. Oversee IVRS or web-based patient randomization processes for assigned projects.

7. Oversee the development of Data Management Plans (DMPs) for assigned projects.

8. Provide statistical input into Case Report Forms (CRF) design for assigned projects, and oversee efforts in developing, reviewing and testing of the CRFs.

9. Provide statistical and programming input into database design for assigned projects, and oversee efforts in development, validation and testing of the study databases.

10. Participate in Study Manual Development, and in clinical trial initiation meetings such as investigator meetings, site monitor/coordinator training sessions. Address statistical and data management questions/concerns from the meeting participants. Train site personnel on data management requirements and procedures.

11. Oversee data management activities for assigned projects. Serve as primary contact between medical/clinical and data management in data related issues.

12. Oversee programming support activities for assigned projects. Validate the accuracy, consistency and integrity of the statistical output displays generated by the Study Programmer.

13. Perform statistical data analyses. Write statistical and data management sections of the joint medical and statistical Study Reports for assigned projects.

14. With assistance from the Archivist, archive study documentation upon the completion of final Study Reports.

15. Participate in evaluating the performance of assigned project personnel.

16. Follow up on the development and implementation of new statistical and data management methodologies which will improve current/future decision making or divisional/corporate business processes, and on the statistical/data management related regulatory requirements and practices. May provide specialized training in an area of technical, professional or business expertise.

17. Participate and contribute to the training and development of new biostatisticians.

18. Lead efforts in the development, maintenance and adherence to divisional SOPs and guidelines.

19. Lead efforts in the development, maintenance and adherence to therapeutic area specific standards and conventions, and be the primary knowledge holder of sponsor specific requirements.

The weight for each of the above accountabilities/duties will depend on the size of the Statistical Sciences and Project Management division/the company. When the size is small, more weight will be put on hands-on project management and statistical work; when the size is bigger, more weight will be put on supervisory and business management work.

For new Biostatisticians to the company, SAS training in the local programming environment will be provided by the internal SAS programmers. Intensive SAS programming for statistical analysis and the generation of statistical tables, listings, and graphs will be a requirement for the first year on the job.

MINIMUM HIRING REQUIREMENTS:

A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 3 years relevant experience or a master’s degree plus 6 years relevant experience with demonstrated ability and sustained performance at the Ph.D. level.

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！