生物统计学岗位职责

The role is responsible fproviding strategic tactical direction fthe companys biometrics activities including statistics, programming, data management. Responsible fthe leadership, oversight, execution of biometrics deliverables fclinical development plan, clinical trial design, data analysis interpretation, regulatory submissions etc.
Key Responsibilities
1. Set up build up the function team to meet the business needs;
2. Provide leadership to all aspects of biometrics ensure overall effective operations in biostatistics, clinical data management, clinical/statistical programming;
3. Establish practices drive the creation of functional SOPs/WIs fclinical data management, biostatistics, statistical programming;
4. Maintain the function training matrix deliver the function required training to company staff and/project staff;
5. Ensure that projects are carried out within the set timeline, quality standards budget, in accordance with business requirements;
6. Oversee lead biometrics input in clinical development plans, clinical trial design, regulatory documents, publications, internal external meetings presentations;
7. Oversee provide hands-on support to ensure the statistical integrity of analysis reporting deliverables, including statistical methods, optimization of study designs, endpoint selection, authoring reviewing;
8. Oversee function-related vendselection supervise biometrics related work regardless of whether it is implemented in-house out-sourcing to third partyganizations;
9. Accountability fthe consistency accuracy of CRO data management statistical programming deliverables, including derived data definition, analysis file structure, analysis methodologies results;
10. Develop working relationships with internal partners as well as external investigators, researchganizations, thought leaders. Responsible ffinal data check data integrity of all outward-facing materials;
11. Report the team key progress, key issues/actions to the CMO company senimanagement team;
12. Other work as assigned by the company.
Qualifications
1. Master in biostatistics statistics, PhD is preferred.
2. 10+ years of biopharmaceutical industry experience is required 5+ years management experience.
3. Relevant pharmaceutical industry experience.
4. Good verbal, written presentation skills in English Chinese.
5. Expert in the principles techniques of statistics, data analysis/interpretation clinical trial design.
6. Demonstrated track record of having led the biometrics team in data collection/analysis/reporting supporting global regulatory submissions.
7. Expert level of proficiency with SAS and/other statistical software packages.
8. In depth knowledge of the drug development process, worldwide regulatory requirements, clinical trial methodology complex statistical designs is preferred.
Traits:
1. High degree of accuracy with attention to details
2. Willing able to learn quickly in a fast-paced environment
3. Strong attention to detail
4. Good communication skills & excellent team player