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Sr. Analyst, Stats Programming

External
neurocrine logoNeurocrine · San Diego, CA
Full-timeOn-site3w ago
Clinical TrialsExcelSAS
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About the role

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

Requirements

  • 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

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