• Responsible for the strategy, direction and execution of clinical development plans including Phase 1 through 3, lifecycle management, medical affairs, safety responsibilities, scientific interactions with regulatory bodies. Ensure clinical development plans are executed on time and within budget.
• Oversees tactical development of clinical trial programs, including literature reviews, clinical CRO/investigator selection, protocol development, interpretation of clinical data, and proactive detection of operational issues; proposing operational resolution including protocol amendments.
• Identifying strategic issues for therapeutic indications under investigation. Keep abreast of critical evolution of therapeutic options for chosen therapeutic indications and alert Senior Management colleagues and clinical operation staff to evolving management paradigms
• Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities. Review and sign off on all correspondence to Health Authorities as appropriate. Review submission to Ethics Committees, input into responses to any questions/issues raised and support of operational teams.
• Interact with KOLs and corporate partner(s) and investors .
• Ensure that company practices are compliant with relevant drug regulations.
• Build, grow and manage a high-functioning clinical organization with a focus on staff development and appropriate succession planning.
1. Review/write the statistical part and study design of protocol
2. Review/write SAP/SAR
3. Statistical analysis result consulting
4. Statistical part in CSR writing
5. Apply advanced study design (ie. adaptive design, Bayesian method, dose selection based on model)
6. Sample size estimated consulting
7. Statistical simulation in sample size estimation
8. Support of Business Development
9. Provide training in statistical analysis to internal or clients.
1. Reads and analyzes protocol, statistical analysis plan, CRF and other trial design documents and discusses with other team members such with as biostatisticians and data managers.
2. Develops and debugs simple to complex SAS program in a timely manner
3. Implements statistical analysis plan, data preparation, and data manipulation into SAS programs and macros
4. Create analysis datasets, statistical tables, figures, and listing for clinical trial data.
5. Create CDISC standard datasets (SDTM and ADaM)
6. Participates in the validation of SAS programs and analysis datasets
7. Maintains documentation for SAS programs and validation results
8. Leads and coordinates the programming work for projects involving SAS programming if necessary
9. Coordinates timelines in orders to fulfill the needs of other departments
1. Develop and review the case report form (CRF).
2. Develop and review the database specification.
3. Develop and review the database structure on the database builder.
4. Develop and review the data validation specification.
5. Conduct the database validations including the user acceptance testing.
6. Develop and maintain the CRF library.
7. Develop and maintain the edit checks (ECS) library.
8. Develop and conduct the data review process and dummy data generation.
9. Oversee and coordinate clinical data integration activities as a DMPM.
10. Develop and update the templates of related processes.
11. Develop and manage the working process and standard operating procedures (SOPs).
12. Act as a mentor for the Associate Clinical Data Scientist I
13. Complete other tasks or assignments requested by the Supervisor.