Associate Director/ Director, Biostatistics

Santen Inc in Emeryville is looking for an AD/ Director Biostatistics to join their team. The role is hybrid with a fixed number of days per week expected at office.What you will doThe Associate Director (AD)/Director of Biostatistics will be responsible for coordinating, implementing and managing the biostatistics and clinical data activities as well as supporting the assigned clinical programs as the Lead Biostatistician.Regarding clinical development the AD/Director will develop innovative clinical study designs and lead the effort to perform state of the art statistical analyses in collaboration with clinicians and other project team members from various functional groups at Santen.Furthermore:The statistician will lead data mining and/or AI/ML of clinical or translational data, incorporation of Real World Data and/or digital data and/or imaging data into clinical development, clinical decision-making, and Health Authority interactions for their clinical programs. On the Director you may lead incorporation and analyses of new data types across clinical programs, therapeutic areas, and across regions.This statistician will closely work with the Head of Global Data Sciences, Global Biomedical Science, Clinical Science, Clinical Operation, Medical Affairs, Marketing and with project managers in providing strategic input to the product development plans and product differentiation, study designs, and product registration filings globally.The statistician supports the effort to develop and maintain all standard operating procedures related to statistical analysis, and to implement the CDISC standards. This position is also responsible for the analysis, visualization and reporting of all Clinical data of the assigned clinical programs.Depending on interest the statistician may also participate in non-clinical activities including but not limited to Discovery, Translational Research, Product Development. Depending on interest, Director-level will take additional responsibilities of building collaborations in non-clinical areas of Research and Development or other areas outside of clinical development.Manages and mentors FTE and Contractor biostatisticians including consulting biostatisticians and interns as appropriate. With at least one direct report.Director-level is expected to further drive collaborations with Medical Affairs and Market Access including adoption of cutting-edge statistical methods such as Bayesian statistics, meta-analyses, matching methodologies.External presence as evidenced by presentations, publications in Clinical Development and/or other areas of R&D