Ruolin Zhang

Senior Director of Biostatistics @ IGNIS Therapeutics (Shanghai) Co., Ltd

About

- Over 20 years' comprehensive experience in Biostatistics and Clinical Data Management in multinational pharmaceutical companies and CRO start-up. Rich experience in Clinical Development Plan, trial design and statistical analysis on multiple therapeutical areas including Solid Tumor, Hematologic Neoplasm and Lymphoma, Immunology, Ophthalmology and Diabetes. - Over 10 years people management in Biometrics team set up, Proven leadership in clinical development with successful records and ability to build and lead highly effective teams for excellent result deliverables with quality and integrity. - Deep project life cycle management, finance management and quality system knowledge in CRO service. Rich experience on supervising multiple clinical trial IT systems and vendor management like EDC, CTMS, Central Lab, IWRS and Drug supply system, ePRO. - Expert insights, broad network, and recognized reputation in the field of digitalization, analytics, and data sciences.

Country

China

City

Haidian District

Industry

Pharmaceuticals

Skill

Clinical Data Management, EDC, Inform, Medidata Rave, Oracle Clinical, OpenClinica, Clinical Trials, CRO, Pharmaceutical Industry, Project Management, CDISC, ICH-GCP, GCP, CTMS, Biostatistics, Oncology, SAS, Epidemiology, Phase I, Diabetes

Experience

Senior Director of Biostatistics

IGNIS Therapeutics (Shanghai) Co., Ltd

2023-8 - Present · 3 yrs 2 mos

Beijing, China

VP of Biostatistics and CDM

Yidu Life Science

2019-5 - 2023-8 · 4 yrs 4 mos

北京

Grow and lead the Biometrics and Clinical Data Science team from 3 to 60+ staff members with multi-disciplinary functions including statistics, statistical programming, data management, database design, randomization and trial supply and clinical trial software development. Built the operating infrastructure and quality system including training matrix, SOPs and quality processes to manage biometric studies with in-house capabilities in compliance with NMPA and FDA regulatory requirement. Responsible for business development and project delivery - 40+ NMPA studies, 5 FDA CDISC programming studies, 1 Phase III Oncology iDMC and 20+ RWS/IIT studies. - Established strategic partnership to build the competitive biometric and centralized data monitoring services for efficient clinical development; developed and maintained a good working relationship with big pharma and biotech.

VP of Clinical Data Management and Biostatistics

Beijing Bioknow Information Technology Co., Ltd.

2018-8 - 2019-5 · 10 mos

北京

Provide CRO data management and biostatistics service: - Manage 40+ clinical data management studies and 10+ biostatistics studies. - Recruit first line management of CDM, SAS programming and Biostatistician. Select locations of biometrics team talent pool. Develop department budget/cashflow forecast. - Draft SOP/WI/AD and JD/CV matrix. - Develop BD proposal/budget and slide deck template. EDC/RTSM/MedCoding/ePRO Software design

Director of Clinical Data Management

Pharmaron Clinical Services

2017-3 - 2018-6 · 1 yr 4 mos

Beijing/Nanjing

Team building and development: - Build China and US clinical data manager and database designer team, set up 4 sites. Quality and Training: - Develop SOP/WI/AD and JD/CV matrix, set up Quality Management and Quality Control. - Develop regulations and technical systematic training/practice/exam for DM and DBD. BD and Projects: - Business development, evaluate RFP/RFI, draft proposal and budgetary review, present on BD meeting. Win DM service for over 60+ DM full service trial. - Responsible for 35+ongoing study, assign resource and issue escalation in DM full service. Database Programming:

Head of Clinical Data Operation

Chiltern

2015-5 - 2017-3 · 1 yr 11 mos

Shanghai/Beijing

Data Management Team Lead

Pfizer

2013-11 - 2015-5 · 1 yr 7 mos

shanghai

Manager of Data Management

Covance

2011-1 - 2013-11 · 2 yrs 11 mos

beijing

- Build Beijing data management team from 1 to 17 within 7 months. - Manage delivery of multiple projects through the full data management study life-cycle. Serve as lead data manager for Asia-Pacific region studies.