Senior Director, Statistical Programming
PharmaCRORegulatory AffairsQuality Assurancesasemafdacroraveinform
Job description
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 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 ) At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

 About the Role: Leads departmental initiatives by providing vision, strategic planning, and management. Offers guidance and mentorship to statistical programming team members. Manages planning and execution of Statistical Programming for data analysis and reporting across Neurocrine studies. Acts as the expert resource within Neurocrine for Statistical Programming matters across departments. _ Your Contributions (include, but are not limited to): Implements vision and strategic direction for Statistical Programming Creates statistical programming strategy input for the preparation of marketing applications (e.g., New Drug Application (NDA) submissions to the FDA) Oversees and monitors statistical system landscape, monitoring industry trends, evaluating novel tools for potential company use and ensuring that systems and resourcing models are scalable for the future Responsible for ensuring that the company's clinical data and statistical software needs are scalable with oversight on all aspects of acquiring and installing new software, including the identification of software requirements, and oversight of the installation, validation, and maintenance Oversees long-term workforce planning for the department ensuring enough and right balance of in-house and contract resources are available to support the analysis and reporting of data from clinical studies for all current and future corporate development programs Manages all external vendors from identification, selection, monitoring contractual work product quality standards and timeliness and ending relationships as needed Implements and manages the development and revision of department statistical programming standard operating procedures. Trains both in-house and contract statistical programmers on standard operating procedures and that all required training is completed and documented Builds relationships with internal and external customers Develops and manages statistical programming budget and vendor budgets; oversees proposal requests from external vendors and negotiates costs, as appropriate Performs other job related duties as assigned Requirements: Typical Experience or Education: BS/BA degree in a computer science, mathematics, statistics, or related field AND 15+ years of experience in the biopharmaceutical or Contract Research Organizations (CRO) industry with extensive experience in a leadership role, leading teams of in-house and/or contract statistical programming management / staff. OR Master's degree in a computer science, mathematics, statistics, or related field AND 13+ years of similar experience noted above OR PhD in a computer science, mathematics, statistics, or related field AND 10+ years of similar experience noted above Common Knowledge & Skills: Acts as a "trusted advisor" across the company and may be recognized as an external expert Provides strategy, vision and direction regarding issues that may have company-wide impact Requires in-depth knowledge of the functional area, business strategies, and the company’s goals Must be self-motivated and detail-oriented Ability to quickly learn and think independently Excellent leadership, coaching and employee development skills Ability to effectively lead a team of statistical programmers with demonstrated proficiency in the hiring, training, and supervision of in-house and contract statistical programmers Excellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company Ability to work with a team of individuals to meet organizational goals Possesses industry-leading knowledge pertaining to clinical and regulatory aspects of a pharmaceutical company. Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact Ability to apply advanced analytical thought and judgement Ability to work in a cross-functional team and a matrix environment Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines Excellent interpersonal skills and problem-solving capabilities Job Specific Knowledge & Qualifications: Expert knowledge of industry systems landscape and pr
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