知名医药研发公司-Senior Biostatistician
北京科诺思通咨询有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:专业服务(咨询、人力资源、财会)
职位信息
- 发布日期:2019-01-17
- 工作地点:上海
- 招聘人数:3人
- 工作经验:无工作经验
- 学历要求:招3人
- 语言要求:不限
- 职位月薪:30-60万/年
- 职位类别:生物工程/生物制药 临床数据分析员
职位描述
1. Provide leadership/expertise in day to day statistical and programming team operations and in resolving complex problems for assigned projects, or as a consultant to others.
2. May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but 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 customer relationship management plans.
· Participating in new business development and bidding processes.
3. Act as Lead Biostatistician/Teammate 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 programming techniques to deliver quality and timely deliverables.
5. Plan, develop and monitor timelines for statistical and programming activities in accordance with medical/clinical activities for assigned projects. Jointly with immediate management, assess statistical and programming resource needs and manage the assigned resources to the projects.
6. Write Statistical Analysis Plans (SAPs) for assigned projects. Perform review on the SAPs written by others.
7. Provide statistical input into the development of study concept, protocol synopsis, protocol, and protocol amendments.
8. Perform review of clinical trial documents, including but not limited to the following: study concept sheet, protocol synopsis, protocols and amendments, statistical and programming documents generated by others, and clinical study reports or publications.
9. Develop or perform review of statistical programming technical specifications, which include but not limited to the following: clinical trial data handling rules, statistical derivations/algorithms, SDTM and ADaM dataset specifications, and statistical testing/modeling approaches.
10. Perform quality control (QC) activities on statistical datasets such as SDTM and ADaM datasets. These activities include but not limited to the following: perform independent statistical programming to validate the datasets, perform QC review of the datasets, assess and recommend resolutions on discrepancies between the datasets generated by two Statistical Programmers or Biostatisticians.
11. Perform quality control (QC) activities on statistical analysis results or data displays such as statistical summary tables, listings, and graphs (TLGs). These activities include but not limited to the following: perform independent statistical programming to validate the TLGs, perform QC review of the TLGs, assess and recommend resolutions on discrepancies between the results generated by two Statistical Programmers or Biostatisticians.
12. Generate or perform QC on clinical trial patient randomization codes and treatment assignments. Oversee IxRS (IVRS and IWRS) implementation of patient randomization codes and treatment assignments for assigned projects.
13. Provide statistical and programming input into clinical trial Case Report Forms (CRF) design for assigned projects, and may provide input to the database design data flow, variable naming conventions and data structure, etc. when required.
14. Participate in clinical trial kick off meeting, investigators meeting, and ongoing trial management team meetings as per project requirements.
15. Write statistical and results sections of the Clinical Study Report, or perform QC review of the CSR.
16. Provide statistical and programming support to clinical trial results dissemination activities, such as generation of data reports for abstracts, manuscripts, posters, and presentations, etc.
17. With assistance from the Archivist, archive study documentation upon the completion of final Study Reports.
18. Participate and contribute to the training, mentoring, and development of new Biostatisticians or Statistical Programmers.
19. Adhere to company governing documents (policies, SOPs, work instructions, templates and checklists), may contribute to the further development of these documents.
20. Contribute to organization development and growth by participating in the interview and evaluation process for job applicants.
21. Plan and carry out professional development.
公司介绍
成立于2012年的CGP,脱胎于传统的猎头公司,拥有近400名专业人士为跨国公司与本土企业提供猎头、招聘流程外包和派遣服务,目前已成为亚洲***的提供招聘解决方案的公司之一。
公司在中国大陆有14个办公室,并在中国香港,新加坡和美国都设有办公室。
在2018年,公司大力发展线上的拥有强大AI匹配技术的招聘平台,并获得了多个业内奖项,包括***招聘机构和具创新能力招聘机构。
Human Resources Asia Recruitment Awards 2018
- ***招聘机构 - 最终大奖
- 具创新能力招聘机构 - 金奖
RI Asia 2017-2018
- 最具潜力招聘服务商
- 中国***招聘服务商
Top HR 2018
- 最具发展潜力本土猎头机构大奖
- 中国猎头行业排行榜内资 TOP 3
联系方式
- 公司地址:地址:span来福士办公楼11楼