岗位职责：

1. Lead Statistical activities for (multiple) assigned clinical studies to ensure scientifically sound study designs and analyses and quality & timely delivery of Statistical deliverables with minimal guidance

a. Study concept, synopsis and protocol development by helping to determine sound study design, estimating sample size.

b. Interact with internal study review committees and address comments from Statistical perspective.

c. Statistical Analysis Plans (SAP) development and execution.

d. Design and preparation of data collection forms and data tabulations.

e. Statistical Analysis Report (SAR) development and interpretation.

f. Clinical Study Report (CSR).

g. Other Statistical consultations as needed.

2. CRO / Vendor Oversight for outsourced studies.

a. Participate in drafting vendor specifications, request for proposal (RFP), scope of work (SoW) for CRO selection.

b. Guide CRO/vendor biostatistician and statistical programmers in terms of study design, analysis methodologies and accuracy of analysis results.

c. Manage CRO/vendor to ensures timely delivery of high-quality Statistical deliverables.

3. Provide Statistical input in study operational documents as needed, such as Data Management Plan, Clinical Monitoring Plans.

4. Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel.

5. Assist with preparation of scientific manuscripts and publications.

6. Contribute to internal/external educational initiatives directed at teaching biostatics and research design.

7. Represent Statistics at investigator meetings and other external investigator/expert interactions.

8. Provide reports, status updates, feedback and advice related Statistics activities to key study stakeholders on study progress.

9. Creates or reviews study level timelines for Statistics deliverables.

10. Provide input to the development of budgets forecasts for studies in planning.

岗位要求：

1、Education

• Master’s degree in health or science related disciplines, such as mathematics, biostatistics/statistics, epidemiology, data science, computer science, etc. PhD degree preferred.

2、Experience

• 3-5 years of analytical experience with epidemiologic/public health studies and/or clinical trials (sponsor-led and outsourced) in pharmaceutical/biotechnology companies or CROs

3、Language

• Strong oral and written communication and presentation skills in Chinese and English

• Other language skills are a plus

4、Competency

• Ability to perform data preparation, descriptive analyses, comparative statistics, and advanced statistical modelling

• Practical understanding of statistical modelling and its application to real-world clinical problems

• Ability to interpret technical medical data and generate sound recommendations to support clinical research efforts

• Ability to effectively present information and respond to questions from project teams, review committees, sites, and external vendors

• Knowledge and experience in working with secondary data sources is a plus

• Maintains awareness of new statistical methods, tools, and data sources to ensure that projects represent the current state of science and maintains professional knowledge and up-to-date statistical methods

• Solid understanding of the scope and focus of clinical trials (Ph 1-4) and non-interventional studies

• Strong working knowledge of applicable regulatory and industry requirements (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, GCP, GPP) and their application to Statistical practice

• High attention to detail and the ability to work individually, within a multi-disciplinary team, and with external partners and vendors

• Ability to prioritize multiple projects and deliverables, along with effective time management skills

• Understanding of clinical medical concepts and terminology

5、Computer Level

• Proficiency in Microsoft® Office software

• Proficiency in scientific computing/programming software and applications, such as SAS or R