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.

Responsibilities

• Development and documentation of programs used in the production of computer generated outputs for clinical study reports, registration and submission documents, publication requirements plus any other document used to present clinical trials data

• Communicate with statistician and medical manager to fully understand analysis requirements for assigned clinical projects

• Perform all SAS programming tasks with high quality in the agreed timeline, and work closely with data management to assure data quality

• Participate in review of protocol, statistical analysis plan (SAP), data management plan (DMP) and case report form (CRF)

• Preparation of electronic submission of clinical data

Education/Qualifications

• BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation

• In-depth knowledge of Base SAS, SAS/STAT, SAS Graph, SAS SQL and SAS Macro Language. SAS Certification is preferred, not required

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

• Effective communication skills and ability to establish and maintain effective working relationships with study team members

• Ability to work under pressure and manage multiple projects simultaneously

• Solid analytical and problem solving skills paired with strong attention to detail

• Experience in CDISC, aCRF and XML is preferred

Experience

2-6 years of related experience

上班地址：新天地中海国际中心（地铁1，9、10、13号线）