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:
Provides strategic planning and management for selected projects and departmental initiatives. Directs biostatistics activities for Neurocrine clinical studies from trial design, execution, analysis, and data interpretation. Serves as the subject matter expert and provides leadership to support all clinical studies, regulatory submissions, and publications. Manages a Biostatistics area, including the technical and administrative oversight of the biostatisticians in the area._
Your Contributions (include, but are not limited to):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
Requirements: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
#LI-SW1
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.
_
The annual base salary we reasonably expect to pay is $234,900.00-$340,100.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.