Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (*in collaboration with AbbVie)
Designs, develops, tests, maintains, validates, and documents SAS programs to evaluate clinical data and meet the project requirements for SAS statistical programming efforts for clinical and non-clinical projects and studies. Provides technical expertise to the development of programming standards and procedures.
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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
We will make multiple hires at this level.
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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.
