Sr. Director, Biostatistics

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.

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, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• Supports the creation of strategic plans and the implementation of corporate/organizational policies in the Biostatistics area under supervision

• Oversees the responsible Biostatistics area, 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 input and support to the development of clinical plans, publications, and studies under the direction of senior biostatistical leadership

• 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

• Develops 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

• Performs other duties as assigned

• Masters degree statistics or similar field preferred and 13+ years 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 reporting of clinical studies, including innovative and adaptive study designs and advanced statistical analysis methods. Extensive previous leadership experience required. OR

• PhD in statistics, biostatistics or related discipline preferred and 10+ years of similar experience noted above

• Significant expertise in the design, analysis and reporting of clinical studies, including innovative and adaptive study designs and advanced statistical analysis methods

• Significant experience with regulatory submissions, and oral and written interactions with regulatory agencies

• Extensive experience with Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting

• Demonstrated leadership skills as biostatistics lead on multiple clinical programs

• Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data

• Demonstrated experience with handling multiple projects at one time and directing resources appropriately to address frequent changes in priorities

• Exhibits ability to become company-wide advisor and emerging industry expert

• Demonstrated strategy development and implementation within areas of responsibility

• Possesses expert knowledge of own function and broad knowledge of multiple functions and impact on business

• Proven leadership skills and ability, including influencing across many levels of the organization

• Ability to effectively manage, mentor and train personnel and ability to motivate and influence personnel to achieve goals

• Excellent problem-solving skills and demonstrated experience with proactively identifying issues and determining appropriate solutions to complex problems

• Must be self-motivated, detail-oriented, decisive

• Ability to quickly learn and think independently

• Excellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company

• Ability to work with a team of individuals to meet organizational goals

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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