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 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, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

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• Serves as the primary project team representative, delegating work as appropriate

• Generates SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains

• Generates analysis data sets, tables, figures, and listings to support the analysis of clinical trials data

• Reviews output across programs to ensure consistency

• Reviews maintains and approves study documents per standard procedures

• Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests

• Programs, tests, and documents global utility programs and tools in accordance with standards and validation procedures

• Provides technical expertise to the development of programming standards and procedures, technical expertise in the areas of analysis and reporting

• Participates in the development and/or maintenance of departmental procedures and standards

• Performs programming using techniques such as macro language, advanced data manipulation, and statistical procedures

• Implements data management plans designed to meet project and protocol deadlines

• Acts as a liaison between clinical management, subcommittees and project teams as needed

• May train and mentor new programmers

• Performs other duties as assigned

• BS/BA degree in computer science, mathematics, statistics, or related discipline and 4+ years experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph). In addition, must have at least three years of experience serving in a supervisory or lead capacity. Experience managing projects OR

• Master's degree in computer science, mathematics, statistics, or related discipline and 2+ years of similar experience noted above OR

• PhD in computer science, mathematics, statistics, or related discipline and similar experience as noted above

• 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

• Strong interpersonal skills to effectively work in a team environment

• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines

• Proficiency with Word, Excel, and PowerPoint is required as is the ability to communicate effectively both verbally and in writing

• Demonstrates strong knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines

• Strong programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar

• Strong knowledge of SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains

• Strong knowledge of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems

• Strong understanding of relational databases and experience working with complex data systems

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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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