Sr. Biostatistician
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About the role
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 ) Serves as the statistical lead for multiple clinical studies, representing Biometrics on one or more study management teams. Provides statistical direction and support for study design, analysis, and reporting, in order to expedite the conduct and evaluation of clinical trials and basic research. Performs statistical analysis of clinical trial data. _ Your Contributions (include, but are not limited to): Represents Biometrics on one or more study management teams, as appropriate for the clinical program Collaborates with Clinical Development and Medical Writing project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports In collaboration with the program lead statistician, identifies appropriate, efficient experimental designs and defines analysis endpoints. Develops randomization plans and determines appropriate statistical methods of analysis for clinical studies Reviews clinical study database data validation specifications, data review plans, coding guidelines, and data transfer agreements Prepares statistical analysis plans for approval Works closely with statistical programmers to ensure that statistical methods are implemented correctly in statistical programs and collaborates with programmers in developing formats and specifications for summary tables, figures, and listings Monitors and reports on CRO performance of statistical analyses and programming to ensure that timelines are met, resource issues are identified and resolved, and all applicable data and programming standards are adhered to Provides biostatistical support to nonclinical, medical affairs, and commercial areas of the company Assists in the development of department standard operating procedures and statistical analysis plan and report templates, data standards, and selection and implementation of statistical software Performs independent research as needed and explores, develops, and implements new statistical methods for the analysis of clinical study data Performs other duties as assigned