Associate Director, Biostatistics
Supporting the BTK-3111 clinical development with a focus on hematology area, the position will work with the clinical and regulatory team in designing clinical trials and developing the statistical analysis plan, facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts, perform statistical functions for submission related activities and serve as internal statistical expert in the overall program. The position will participate in process improvement, training, SOP development, enhancing statistical technical expertise and mentoring junior statisticians as a senior member of biostatistics department.
This individual will interface with clinical therapeutic area members, SAS programming, clinical data management, clinical operation, clinical pharmacology, medical writing and other functions. This position will also participate in managing vendors to ensure quality of all deliverables’ and adherence to requirements/timeline.
A minimum of a Master’s Degree with 8+ years of experience or a PhD in Statistics or related field with 4+ years of experience in clinical drug development is required. Knowledge of SAS and/or R is strongly desirable. Experiences with clinical trials and knowledge of regulatory guidance are required. Hematology experience is preferred but not required. Demonstrated written and oral communication skills and ability to work within a team and work independently are required. Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision making capability.
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