Biostatistics Director

Who We Are:

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)

About the Role:

Develops strategic and operating plans for area of responsibility. Serves as overall statistical lead and point of contact representing Biometrics in partnership with Medical Affairs, Health Economics and Outcomes Research (HEOR), and other departments to support the development and execution of real world evidence (RWE) strategies, protocol development, analysis plan development, implementation of analyses, interpretation of findings and dissemination/publications. Ensures scientific rigor and serves as the analytical methodology expert for RWE study designs and data analyses across various data types and applications.

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

• Serves as statistical lead and represents Biometrics on health outcomes and epidemiology studies

• Provides strategic and tactical support for cross-functional RWE development for regulators, payers and clinicians

• Serves as subject matter expert for RWE/HEOR research design, methodologies, data sources, analytic techniques, and reporting

• Leverages administrative claims, electronic medical records, or other real-world data and recommends optimal study designs

• Selects and implements appropriate analytical methods including statistical models or machine learning models to align with overall business objectives

• Develops high quality study protocols, statistical analysis plans, study reports, and other study documents

• Ensures quality and consistency of analytics deliverables

• Identifies innovation opportunities for the use of RWD

• Establishes effective communication with various internal stakeholders to understand and support the strategy for when and how to use RWE

• Collaborates with and manages vendors to ensure project timelines and goals are met

• Performs other duties as assigned

Requirements:

• Master’s degree in statistics, biostatistics or related discipline AND 10+ years of experience leading the design and conduct of observational research in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements, and the development of drug development strategies in the pharmaceutical industry setting including innovative study designs and advanced statistical methods. Extensive previous leadership experience required. OR

• PhD in statistics, biostatistics or related discipline AND 7+ years of similar experience as noted above

• Internal thought leader and recognized expert in a discipline

• Requires broad expertise in theories and techniques within a area of responsibility

• Ability to drive strategic direction into tactical plans

• Strong mentoring skills and leadership abilities may mentor/coach lower levels and/or leads indirect teams

• Experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements

• Knowledge of global regulatory and HTA requirements for RWE

• Demonstrated ability in evaluation and development of RWE from conceptualization through application

• Experience leading the design and conduct of observational research, including protocol, statistical analysis plan, and study report development

• Extensive working experience with stakeholders such as medical affairs and health economics

• Hands-on experience with prospective and retrospective observational studies

• Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries

• Excellent organizational skills and proven ability to effectively lead multiple projects to successful completion

• High level of competency using standard statistical software such as SAS or R

• Ability to effectively interpret and communicate research results to internal and external audiences

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.