Sr. Director, Biostatistics bei Neurocrine

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.

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)

About the Role:

Provides strategic planning and management for selected projects and departmental initiatives. Directs biostatistics activities or related quantitative scientific work for Neurocrine clinical or observational studies from design, execution, analysis, and data interpretation. Serves as the subject matter expert and provides leadership to support all clinical or observational studies, regulatory submissions, and publications. Manages a focused expertise area, including the technical and administrative oversight of the professional staff in the area.

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

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

• Supports the creation of strategic plans and the implementation of corporate/organizational policies in Biostatistics or a related quantitative science area under supervision

• Oversees the responsible area, including the day-to-day management activities as well as technical leadership and coaching for the staff

• Serves as the functional area lead for one or more Neurocrine clinical or observational study programs, which includes serving as lead biostatistician or epidemiologist, 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 analytics and data sciences leadership

• Researches, develops, and implements statistical or observational research methods appropriate to 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 as the functional representative in discussions and meetings with regulatory agencies

• Develops functional processes and procedures, including the writing and review of department standard operating procedures

• Makes final decisions on administrative or operational matters related the functional or expertise group under supervision and ensures effective achievement of objectives

• Performs other duties as assigned

Requirements:

• Masters degree statistics, biostatistics, epidemiology 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 or observational studies, including innovative and adaptive study designs and advanced analytical methods. Extensive previous leadership experience required OR

• PhD in statistics, biostatistics, epidemiology 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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Requirements:

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, 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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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. Jetzt bewerben