Major responsibility and duties - Oversees the delivery of or directly perform analysis, interpretation, design, and reporting or communication of data evidence for clinical development needs. - Develop and implement innovative statistical approaches in clinical development, with hands-on implementation through direct interactions with statisticians, clinical teams and other relevant partners. This involves, but is not limited to developing/identifying appropriate designs and methods, decision rules (e.g., Go/No Go); planning, running, and summarizing simulation studies to evaluate the operating characteristics of alternative designs and methods under a range of scenarios; and participating in the implementation of the selected approaches by engaging in protocol and SAP write-up. - Collaborate with external consultants and qualified CROs to provide support in the development and implementation of innovative methods and designs. - Provides leadership support through hiring, developing and training statistical team members.
Qualifications - Ph.D. or Master in Statistics or related field - Proficient in SAS or R programming.
- At least 4 years’ relevant experience for Master, or at least 2 years’ relevant experience for Ph.D. - Know well about statistical methods of clinical trials. - Know well about study design and process of clinical trials.
- Good written, oral, and interpersonal communication skills. - Demonstrated people leadership and management skills. - Has an advanced understanding of regulations and guidelines.