Sr. 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 or related quantitative scientific work for Neurocrine clinical or observational studies from design, execution, analysis, and data interpretation. Serves as the subject matter expert and provides leadership to support all clinical or observational studies, regulatory submissions, and publications. Manages a focused expertise area, including the technical and administrative oversight of the professional staff in the area._
Your Contributions (include, but are not limited to):
Your Contributions (include, but are not limited to):
Supports the creation of strategic plans and the implementation of corporate/organizational policies in Biostatistics or a related quantitative science area under supervision
Oversees the responsible area, including the day-to-day management activities as well as technical leadership and coaching for the staff
Serves as the functional area lead for one or more Neurocrine clinical or observational study programs, which includes serving as lead biostatistician or epidemiologist, 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 input and support to the development of clinical plans, publications, and studies under the direction of senior analytics and data sciences leadership
Researches, develops, and implements statistical or observational research methods appropriate to 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 as the functional representative in discussions and meetings with regulatory agencies
Develops functional processes and procedures, including th
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