上海招聘

POSITION OBJECTIVE:

Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems. Provide technical leadership and oversight to project teams while performing hands on work with complex tasks as well as with quality control activities. Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc. Participate in developing and maintaining clinical trial data and statistical reporting standards. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.

KEY ACCOUNTABILITIES: 

1.        Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems.

2.        Perform a leadership role in statistical programming projects by coordinating study team(s), overseeing timelines, assigning and following up on programming tasks, interacting with clients, and ensuring quality of programming deliverables.

3.        Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers’ skills and expertise, as well as availability.

4.        Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.

5.        Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.

6.        Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.

7.        Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.

8.        Perform 3rd level QC review on programming deliverables before their release to the clients.

9.        Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc.

10.     May lead programming efforts for drug development programs or for assigned client clusters.

11.     Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.

12.     Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents.

13.     May represent the company in interactions with clinical trial sponsors with regard to statistical programming projects and relevant businesses.

14.     Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices.

15.     Participate in statistical programming project bidding or bid defense meetings.

16.     Work with document management specialists/archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects. Perform transfer of the archived files to the clinical trial sponsors.

QUALIFICATIONS AND EXPERIENCE:

Education: M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.   Years of Experience: 10 (M.Sc., M.A.)/9 (Ph.D.) years' related experience.   Type of Experience/Knowledge Base: An in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies. Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.    Type of Skills or Training: Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies. Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations. Must have sound technical judgment and experience in process design and implementation in relevant areas. Strong leadership and drive to achieve goals will be required.              

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！