Director, Biostatistics- San Diego based

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, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Develops strategic and operating plans for area of responsibility. Serves as the overall statistical lead on multiple clinical programs and will provide statistical input in design, analysis, and reporting of clinical studies to expedite the conduct and evaluation of clinical trials and basic research. Leads statistical analysis and maintains standards across studies within a clinical program. Interacts with key opinion leaders on protocol design. Oversees and directs the biostatistics team responsible for the analysis and reporting of data from clinical studies.

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Your Contributions (include, but are not limited to):

• Manages in-house and contract biostatisticians to support the analysis and reporting of data from clinical studies for clinical development programs

• 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

• Represents Biometrics on one or more Dev Core Team or clinical sub team (as appropriate for the clinical program)

• Collaborates with Clinical Development, Medical Writing, and Regulatory Affairs project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports

• Identifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines appropriate statistical methods of analysis for clinical studies

• Represents Biostatistics in interactions with regulatory agencies

• Prepares, reviews, and approves statistical analysis plans

• Oversees and monitors 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 as needed

• Leads the development of department standard operating procedures, statistical analysis plan and report templates, data standards, and selection and implementation of statistical software

• Reviews, approves and implements new and innovative statistical methods for the analysis of clinical study data and adaptive study designs

• Assumes a leadership role in clinical program(s), with the responsibility of ensuring that the statistical requirements are met for all projects in the program(s)

• Performs other duties as assigned

Requirements:

• Master’s degree in statistics, biostatistics or related discipline and 10+ years of experience with Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting, particularly the design, analysis and