Senior Director, Statistical Programming

Neurocrine Biosciences•San Diego, CA

10d

About The Position

The Senior Director, Statistical Programming leads departmental initiatives by providing vision, strategic planning, and management. The role guides and mentors statistical programming team members, manages planning and execution of statistical programming for data analysis and reporting across Neurocrine studies, and serves as an expert resource on statistical programming across departments. The position sets strategic direction for statistical programming, including input into programming strategy for marketing applications such as FDA New Drug Applications. It oversees the statistical systems landscape, evaluates emerging tools, and ensures systems and resourcing models can scale for future needs. The role also oversees acquisition, installation, validation, and maintenance of clinical data and statistical software. The Senior Director plans the department’s workforce, manages external vendors and their work quality and timelines, develops and maintains departmental procedures, and ensures employee and contractor training is completed and documented. The role builds internal and external relationships, manages departmental and vendor budgets, oversees vendor proposals, and negotiates costs as appropriate.

Requirements

Bachelor’s degree in computer science, mathematics, statistics, or a related field and 15 or more years of biopharmaceutical or CRO industry experience, including extensive leadership experience managing in-house and/or contract statistical programming teams; OR a master’s degree in a related field and 13 or more years of similar experience; OR a PhD in a related field and 10 or more years of similar experience.
Expert knowledge of industry systems and demonstrated ability to identify and evaluate systems for company use.
Expertise in SAS programming and developing and implementing statistical programming procedures and processes in a clinical development environment.
Advanced knowledge of regulatory guidelines and requirements relevant to clinical study design, analysis, reporting, and submission of studies and data.
Advanced knowledge of writing, validating, and documenting statistical programs and creating integrated programming libraries and systems.
Solid knowledge of SDTM and ADaM datasets and development of integrated databases.
Demonstrated record of delivering statistical analysis in support of the drug development application process.
Demonstrated success in end-to-end vendor management.
Extensive experience identifying and evaluating systems.
Ability to act as a trusted advisor and provide strategy, vision, and direction on issues with company-wide impact.
In-depth knowledge of the functional area, business strategies, and company goals.
Self-motivation, attention to detail, ability to learn quickly, and independent thinking.
Excellent leadership, coaching, and employee development skills, including demonstrated ability to hire, train, and supervise in-house and contract statistical programmers.
Excellent interpersonal and communication skills to interact effectively with peers, management, and leadership inside and outside the company.
Ability to work collaboratively toward organizational goals, including in cross-functional and matrix environments.
Industry-leading knowledge of clinical and regulatory aspects of a pharmaceutical company.
Ability to evaluate key business and scientific challenges and complete complex, ambiguous initiatives with cross-functional impact.
Advanced analytical thinking and judgment.
Excellent organization and time management, with the ability to work independently, coordinate workload under pressure, and meet deadlines.

Responsibilities

Implement vision and strategic direction for Statistical Programming.
Provide statistical programming strategy input for the preparation of marketing applications, including FDA New Drug Application submissions.
Oversee and monitor the statistical systems landscape, monitor industry trends, evaluate tools for potential company use, and ensure systems and resourcing models are scalable.
Oversee the acquisition and installation of clinical data and statistical software, including requirements identification, installation, validation, and maintenance.
Oversee long-term departmental workforce planning to ensure an appropriate balance of in-house and contract resources for current and future programs.
Manage external vendors, including identification, selection, monitoring work-product quality and timeliness, and ending relationships as needed.
Develop and revise departmental statistical programming standard operating procedures.
Train in-house and contract statistical programmers on procedures and ensure required training is completed and documented.
Build relationships with internal and external customers.
Develop and manage statistical programming and vendor budgets; oversee vendor proposal requests and negotiate costs as appropriate.
Perform other job-related duties as assigned.