南京招聘

Background

  

Protech Pharmaservices Corporation (PPC) was founded in 1997 to meet the growing demands for R&D outsourcing from the Pharmaceutical and Biotech industries in the Asia- Pacific region. PPC is the largest CRO in Taiwan to offer a complete range of Clinical Research and Contract Laboratories services. In order to build up an international CRO network, PPC has formal alliances in Japan. In addition, PPC has branch operations in China (Beijing, Shanghai), Japan, and Korea.

  

  

About the Job We are looking for (Senior) Biostatistician in PPC Shanghai office. As a (Senior) Biostatistician, you are responsible for providing statistical services on Phase I-IV clinical trials, including but not limited to the responsibilities below:

  

- Assist with protocol development, sample size calculation, protocol and case report form (CRF) review

  

- Advise data management staff on database design, and be responsible for critical data and data quality review

  

- Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule)

  

- Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups

  

- SAS programming and related activities for the presentation and analysis of clinical trial data

  

- Provide support for special committees, e.g., DMCs including input/review of charters and maintenance of appropriate blinding

  

- Responsible for statistical input to statistical reports and Clinical Study Reports

  

- Understand the submission issues, having the ability to communicate with experts in CDE in an effective manner

  

- Support of Business Development, e.g. by attending and preparing bid defense meetings

  

- Interact with clients as key contact with regard to statistical and contractual issues

  

- Provide consulting services in statistical field, which includes but not limited to study design interpretation, problem-solving in implementation, data-examination guidance and research-result explanation

  

  

Education/Qualifications

  

- PhD or Master in statistics/biostatistics, mathematics, epidemiology, or other related data science majors

  

- Good communication skills and ability in building sound relationships

  

- Good collaboration with colleagues, working in a high efficient and cross-functional manner

  

- Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH-GCP etc.)

  

- A good understanding of statistical issues in clinical trials

  

- Understand and apply moderately advanced statistical methods

  

- Ability to work independently

  

PPC佳生集团（PPC Group）是一家成立于1997年的临床CRO公司。总部设立于上海，并分别在台北，徐州，北京，南京，首尔及东京设立了分部及分公司。
     自成立以来我们始终致力于为国内外制药企业及生物技术公司提供专业的临床研究服务及生物样本分析服务。至今，PPC佳生已经完成了超过3000项早期临床试验项目及超过500项II期至IV期临床试验项目，其中涉及24个主要研究领域。
     另外，PPC佳生的I期临床中心及生物分析实验室也分别通过了美国FDA,中国NMPA,台湾TFDA,日本PMDA,欧盟EMA及马来西亚NPRA等的核查。
     2012年，PPC佳生在台北（MacKay Memorial Hospital）建立了***家专属I期临床研究中心；2017年初与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心；2018年，PPC佳生又分别与徐州市中心医院，湖北省鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。截至目前，PPC佳生已有5家自主运营的I期临床中心。