Executive 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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• 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

• Performs other duties as assigned

Requirements:

• Masters degree statistics or similar field preferred and 15+ 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 12+ years of similar experience noted above

• Acts as a "trusted advisor" across the company and may be recognized as an external expert

• Provides strategy, vision and direction regarding issues that may have company-wide impact

• Has in-depth knowledge of the functional area, business strategies, and the company's goals

• Possesses industry-leading knowledge

• Excellent leadership, coaching and development skills

• Excellent oral and written communication skills

• 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

• Demonstrated ability to influence and lead others

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

• 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

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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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