上海招聘

Major Responsibilities and Duties:

1. Provide statistical leadership in support of I-Mab’s China and/or Global pipelines, which includes guidance on statistical methods, appropriate study design and interpretation of results and strategic input into clinical development planning.

2. Contribute to develop company SOPs, process and practice.

3. Collaborate effectively with Clinical Development colleagues by driving statistical thinking, proper data interpretation and disciplined exploratory data analysis.

4. Develop statistical sections of clinical protocols, Statistical Analysis Plans (SAPs) and Statistical Programming Plans (SPPs).

5. Define and lead the analysis of relevant internal and external information to inform design decisions.

6. Be responsible for statistical content and data interpretation for Clinical Study Reports (CSRs), publications/presentations and/or regulatory documents.

7. Perform other statistical analyses duties as needed.

8. Help to develop and maintain I-Mab Lifecycle Data Standards.

9. Oversee CROs regarding statistical and programming activities to ensure compliance, quality and timely delivery.

Qualifications:

1. Education: MS or PhD in biostatistics, statistics or related field is required.

2. Experience: a minimum of 5 years (or 8 years for director) of relevant experience including lead statistician role at compound level within pharmaceutical or biotechnology industry is required. Oncology experience is highly desired.

3. Comprehensive knowledge of advanced statistical methods and applications in study design and analysis.

4. Ability to implement innovative and advanced study designs, particularly in early phase oncology studies.

5. Ability to communicate with clarity and influence.

6. Proficient SAS and/or R programming skills, solid understanding of CDISC standards.

7. Knowledge of ICH/EMEA/FDA guidelines.

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

9. Ability to manage and mentor project/study statisticians.

10. 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。