- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director of Biostatistics will provide strategic statistical leadership for pharmacokinetic (PK) and pharmacodynamic (PD) studies ... across all phases of clinical development. This role partners closely with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs, and Clinical Development to ensure robust study design, insightful data analysis, and timely support for global regulatory… more
- BeOne Medicines (Emeryville, CA)
- …Work with cross-functional study/project teams supporting hematology studies and interact with Clinical, Regulatory, Statistical Programming, Data Management and ... other Research Scientists in reviewing the data, developing and implementing the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission documents. Provides content for manuscripts / presentations and provides… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** As Associate Director of R&D Data Governance, you will spearhead governance framework execution, guide data stewards, operationalize ... as governance liaison for clinical operations, safety, regulatory, and biostatistics teams-translate functional requirements into stewardship tasks and system… more
- Taiho Oncology (Pleasanton, CA)
- …or indirect management of cross-functional areas (eg, clinical operations, biostatistics , data management, biomarker, pharmacovigilance, quality, etc.) + Knowledge ... in authoring key clinical development documents (eg, study protocol, IB, ICF, CRF, CSR, DSUR, PBRER, and documents for regulatory interactions). + Ability to learn, integrate complex information, and manage competing priorities for program deliverables +… more
- Taiho Oncology (Pleasanton, CA)
- …team members (Medical monitor, Project Manager, Clinical Operations, Data Management, Biostatistics , PV, PK, Biomarkers and Medical Writing etc.), to deliver high ... the knowledge for designing and summarizing clinical studies. + Keeps Sr. Medical Director current on status of clinical trials and provides ongoing risk assessments… more