上海招聘

Major Responsibilities and Duties：

1. Serve as the statistical programming functional head for the company.

2. Develop and maintain statistical programming infrastructure, environment, standards, process and SOPs for both China and US operations.

3. Contribute to development of outsourcing strategies and relationships with outsourcing vendors/CROs.

4. Responsible for all statistical programming tasks including submission-readiness datasets (e.g.SDTMs, ADaMs) and TFLs to support CSR, ad hoc analysis, publications, DSUR, and etc.

5. Prepare/Review electronic submission deliverables (e.g. Define.XML, Reviewers Guide, XPTs) consistent with regulatory guidelines.

6. Ensure compliance with FDA and NMPA regulations related to statistical programming including vendors/CROs.

7. Contribute to developing company SOPs, process, practice, guidelines and standards.

8. Oversee and ensure quality of all statistical programming activities performed by CROs.

9. Collaborate effectively with Clinical Operations, Medical/Clinical, safety colleagues and vendors/CROs in support of project deliverables and regulatory needs.

10. Represent statistical programming and effectively communicate requirements, strategy, timelines, and deliverables at internal cross functional team meetings and meetings with external vendors/CROs.

12. Recruit and manage statistical programming staff.

Qualifications：

1. Education: Minimum of bachelor’s degree in scientific, biological, statistical, computer science, or related field. Master’s degree preferred.

2. Experience: A minimum of 8 years of relevant experience and 2 years of managerial experience in pharmaceutical or biotechnology industry is required. Oncology experience is highly desired.

3. Comprehensive knowledge of ICH/FDA/NMPA guidelines.

4. Expert knowledge in SAS is required.

5. Knowledge and experience of CDISC standards (SDTM and ADaM) are required.

6. Experience with electronic submission formats such as eCTD is a plus.

7. Demonstrated ability to serve effectively as a delivery team leader.

8. Ability to manage, mentor and motivate statistical programming staff.

9. Demonstrated ability to effectively collaborate and influence throughout multiple levels of the organization.

天境生物科技(上海)有限公司
天境生物由臧敬五博士领衔的创新药资深研发团队创建，是一家聚焦在肿瘤免疫和自身免疫疾病精准医疗领域的新药研发生物医药科技公司。
公司的核心竞争力在于早期研发、靶点发现和验证、工艺开发&临床前评价、质量科学&质量管理、早期临床研究的能力（包括临床一期和临床二期）。团队在创新药物靶点生物学、创新抗体药物分子结构研发以及创新药物的转化医学及临床研究方面的优势为公司建立一条具有国际竞争力的项目管线创造了基础。公司目前创新药管线含12个在研创新抗体药物项目。领先的创新药项目将在2017年3月申报临床研究并在台湾, 韩国及中国启动临床研究, 其它项目均已进入细胞株或工艺开发阶段。
公司从成立以来已经建立了广泛深入的国际合作, 如与瑞士FERRING公司合作独家引进开发Olamkicept。公司自主研发的全球创新药项目将在2018年进入中国及美国临床研究申报环节并计划在两地启动一期临床研究。