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Main Tasks:
To advise statisticians for problem solution and to give suggestion/input for their smooth operation of works with quality
Ø To assign resource for each work appropriately by realizing their experience, capacity, quality development.
Ø To train statisticians to develop and improve their quality and competency.
Ø To review of work and documentation to assure GCP compliant operations and quality of deliverables from group members.
Ø To assure project completed in compliance with NN Quality system and Core SOPs
Ø To be responsible for continuously improvement of work processes.
Ø To perform goal setting and performance review on staff as per the department goals and BSC
Ø Interview candidates and in conjunction with HR (job advertisements, applicant screening, interviewing of applicants, decision on successful candidate)
Ø Ensure that personnel competencies are maintained and developed to meet future business requirements.
Ø To prepare or support in preparation of trial design, determining the evaluated variables and analysis methodology.
Ø To prepare the quality SAP
Ø To design the derived data set and to make analysis programs
Ø To perform a statistical analysis and to prepare the analysis report
Ø To answer the statistical questions from the authority
Ø To be responsible for continuously improvement of work processes in terms of STAT.
Ø To establish co-operative relationship between corresponding functions in HQ and CDCs.
Qualifications:
Ø Bachelor degree in statistics, or equivalent in mathematics.
Ø At least 2 years of biostatistician experience in pharma industry, demonstrates good understanding of Clinical development and contributes to the whole project. Management experience is preferable.
Ø Strong knowledge and experience in statistical designing and planning clinical trials.
Ø Strong skills in the resolution of SAS programming issues.
Ø Fluent in written and spoken English.
Ø Analytical skills.
Ø Ability to plan and prioritize complex tasks and approach these in a flexible manner.
Ø Ability to be flexible and accommodate to a changing environment
Ø Good communication skills and coaching skills.
Ø The ability to present statistical issues in a clear, logical and non-technical manner to differing audiences.
Ø Excellent organizational and communication skills
Ø Pro-active business focused approach.
Ø Ability to work within a multidisciplinary team, preferably international, and be pragmatic
企業介紹:
About Novo Nordisk Novo Nordisk is one of the world's leading bio-pharmaceutical companies and the world leader in insulin production for diabetes treatment. With headquarters in Copenhagen, Denmark, Novo Nordisk employs approximately 21,000 people in more than 70 countries and markets its products in 179 countries. There are also production plants in occident. Novo Nordisk has a long history since 1923. For over 80 years, Novo Nordisk continues to adopt advanced biotechnology to improve the research and means of production for insulin. It is a major force in insulin manufacture and diabetes treatment. The company was the first to introduce longer acting insulin (NPH and Lente insulin), pre--mixed insulin, highly purified insulin (MC and RI insulin), human insulin and insulin pens, which tremendously improved the level of diabetes treatment and control, and life quality of people with diabetes. In addition, Novo Nordisk is in a leading position within the areas of coagulation disorders, growth disorders and hormone replacement therapy. As early as 1960s, Novo Nordisk's products have been introduced to the China market. In 1994, Novo Nordisk board decided to land a strategic investment project in China. Novo Nordisk (Tianjin) Biotechnology Co., Ltd. was then set up in China. The company's headquarters and Biotechnology R&D Center are located in Beijing while its production plant is in Tianjin. For more information, please visit: http://www.novonordisk.com.cn 諾和諾德公司概覽: 諾和諾德是世界領先的生物制藥公司,在用于糖尿病治療的胰島素開發和生產方面居世界領先地位。諾和諾德總部位于丹麥首都哥本哈根,員工總數21,000人,分布于70個國家,產品銷售遍布179個國家。在歐美均建有生產廠。 諾和諾德的歷史最早可追溯至1923年。近80年來,諾和諾德不斷運用先進的生物技術完善胰島素研究和生產手段,取得突破性進展,成為這一領域的先驅。諾和諾德率先推出長效胰島素,預混胰島素,高純胰島素,人體胰島素和胰島素注射筆。同時,諾和諾德又率先推出新一類的口服降糖藥-諾和龍,從而極大地提高了糖尿病治療和控制水平,改善了糖尿病人的生活質量。此外,諾和諾德還在凝血治療、生長保健以及激素替代療法等很多方面居世界領先地位。 諾和諾德的產品60年代初就已進入中國市場。1994年初,諾和諾德董事會通過了在中國實施戰略投資的計劃,在北京建立諾和諾德(中國)制藥有限公司總部和生物技術研究發展中心,并在天津興建現代化生產工廠。欲了解詳情,請訪問諾和諾德中國網站:http://www.novonordisk.com.cn |
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