Professional：

Statistics, mathematics, computer science, medicine and other related majors;

Participate in more than 10 projects and lead at least 5 of them;

Familiar with SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph and SAS/SQL, proficient in CDISC standards;

Familiar with relevant regulations, such as GCP, ICH, etc.

Job description:

1. Responsible for the implementation of clinical data management and statistical analysis programming;

2. Responsible for directing and executing the writing, reviewing, processing of SDTM and ADaM data set description files and the generation of TFLs;

3. Responsible for verifying SDTM, ADaM and TFLs;

4. Responsible for the annotation and verification of the case report form;

5. Participate in the management of project resources/time schedule/budget;

6. Improve the department’s existing code to ensure the stability and advancement of the department’s programming technology;

7. According to the project test plan, be responsible for quality analysis and issue related test reports.

Professional：

Clinical medicine, pharmacy, public health, preventive medicine, nursing, biostatistics and other medicine-related majors;

Have more than 3 years of relevant project management experience in pharmaceutical company/CRO clinical trial data management;

Familiar with the construction process of mainstream EDC;

Familiar with common systems in the field of clinical data management, familiar with GCP and related requirements

Job description:

1. Independently complete various tasks of data management, including but not limited to reviewing plan data management related content, drafting data management plans and reports, designing CRF, drafting database construction instructions and data verification plans, database testing, and external data consistency verification , SAE consistency comparison, question management, medical coding, document management, database lock and delivery, etc.;

2. Independently lead the data management of the project, including project team formation and training, internal and external communication of the project department, progress control, supplier management, contract review, key time point data delivery (interim analysis, IDMC, database lock library).

Professional：

Statistics, epidemiology and other related majors, with more than 3 years of biostatistics related experience in the pharmaceutical industry;

Familiar with the biostatistics technical guidelines related to ICH and NMPA clinical trials;

Able to use SAS, R and other statistical software proficiently

Job description:

1. Participate in the design of clinical trials, and be responsible for writing the statistical content of the clinical trial plan;

2. Calculate the sample size of clinical research and formulate a randomization plan;

3. Responsible for the statistical analysis plan and the statistical analysis of clinical trials; compile the program to generate statistical graphs, tables or data sets according to the analysis needs, as well as the corresponding description files or reports;

4. Review data management related documents, including but not limited to CRF, electronic data entry guide, data verification plan, and external data transmission protocol;

5. Provide statistical support for the writing of clinical summary reports and support NDA submission.