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 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)
Serves as the statistical lead for multiple clinical studies, representing Biometrics on one or more study management teams. Provides statistical direction and support for study design, analysis, and reporting, in order to expedite the conduct and evaluation of clinical trials and basic research. Performs statistical analysis of clinical trial data.
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Represents Biometrics on one or more study management teams, as appropriate for the clinical program
Collaborates with Clinical Development and Medical Writing project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports
In collaboration with the program lead statistician, identifies appropriate, efficient experimental designs and defines analysis endpoints. Develops randomization plans and determines appropriate statistical methods of analysis for clinical studies
Reviews clinical study database data validation specifications, data review plans, coding guidelines, and data transfer agreements
Prepares statistical analysis plans for approval
Works closely with statistical programmers to ensure that statistical methods are implemented correctly in statistical programs and collaborates with programmers in developing formats and specifications for summary tables, figures, and listings
Monitors and reports on 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
Assists in the development of department standard operating procedures and statistical analysis plan and report templates, data standards, and selection and implementation of statistical software
Performs independent research as needed and explores, develops, and implements new statistical methods for the analysis of clinical study data
Performs other duties as assigned
Master’s degree in statistics or biostatistics, or a related discipline AND 4+ years of relevant experience OR
PhD in statistics or biostatistics, or a related discipline preferred AND 2+ years of relevant experience
Understands key business drivers and uses this understanding to accomplish work
Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
Proficient with tools and processes that support work conducted by functional area
Ability to work as part of a team; may train lower levels
Excellent computer skills
Strong communications, problem-solving, analytical thinking skills
Detail oriented yet can see broader picture for department
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong project management skills
Solid expertise in the design, analysis, and reporting of clinical studies
Strong organizational skills and proven ability to effectively lead the statistical aspects of multiple clinical studies simultaneously
Strong knowledge of the SAS programming language with a specific emphasis in SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data
Good knowledge of CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets
Broad knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data
Experience in interacting directly with regulatory authorities highly desirable
Maintains expertise in modern data manipulation and statistical analysis methodologies
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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 $110,800.00-$151,000.00. 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 20% 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.
