Senior Director, Statistical Programming

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 proven ability to identify and evaluate potential systems for company use.
• Expertise in SAS programming skills and the development and implementation of statistical programming procedures and processes in a clinical development environment.
• Advanced knowledge of regulatory guidelines and requirements relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data
• Advanced knowledge of all aspects of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems
• Solid knowledge of SDTM and ADaM datasets and the development of integrated databases
• Proven track record of delivering statistical analysis in supporting the drug development application process
• Proven success with end to end vendor management
• Extensive systems identification and evaluation experience