Executive Director, Biostatistics
Neurocrine BiosciencesAbout the role
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
About the Role:
Provides strategic planning and management for selected projects and departmental initiatives. Directs biostatistics activities for Neurocrine clinical studies from trial design, execution, analysis, and data interpretation. Serves as the subject matter expert and provides leadership to support all clinical studies, regulatory submissions, and publications. Manages the Biostatistics group, including the technical and administrative oversight of the biostatisticians._
Your Contributions (include, but are not limited to):
Develops strategic plans, corporate and/or organizational policies and authorizes their implementation for Biostatistics
Oversees the Biostatistics group, including the day-to-day management activities as well as technical leadership and coaching for the biostatisticians
Serves as the biostatistics lead for one or more Neurocrine clinical programs, which includes serving as lead biostatistician, working in cross-functional teams to develop the drug development strategy, and coordinating with data management and statistical programming on activities related to clinical studies and other analysis projects
Provides statistical leadership and strategic input to the Dev Core Team in all areas of drug development and commercialization, including the overall clinical development plan, publication planning, and studies
Researches, develops, and implements statistical methods appropriate to clinical study design and objectives and consistent with current regulatory standards and requirements
Participates in regulatory submission planning, including data submission strategies and integrated summaries
Represents Neurocrine biostatistics in discussions and meetings with regulatory agencies
Drives the development of biostatistics processes and procedures, including the writing and review of department standard operating procedures
Makes final decisions on administrative or operational matters related the Biostatistics group and ensures effective achievement of objectives
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