Director, Statistical Programming Standards & Infrastructure

SUMMARY / JOB PURPOSE (Basic purpose of the job) :

The Director of Statistical Programming Standards & Infrastructure provides strategic leadership and oversight for the development, implementation, and maintenance of global statistical programming standards, tools, and infrastructure. This role ensures compliance with regulatory requirements, industry standards (e.g., CDISC), and internal quality processes. The Director will partner with cross-functional teams, including Biostatistics, Clinical Data Management, and IT, to drive innovation, efficiency, and consistency in statistical programming deliverables across studies and submissions.

ESSENTIAL DUTIES / RESPONSIBILITIES :

• Define and execute the vision for statistical programming standards and infrastructure aligned with organizational goals.
• Establish governance for global programming standards, tools, and processes.
• Oversee creation, validation, and lifecycle management of global macros, standard programs, and reusable code libraries.
• Ensure adherence to SDLC principles for all programming tools and infrastructure components.
• Drive initiatives to enhance automation, scalability, and efficiency in programming workflows.
• Collaborate with IT to maintain robust, secure, and compliant programming environments.
• Ensure deliverables meet CDISC standards (SDTM, ADaM) and regulatory requirements (e.g., FDA, EMA).
• Oversee quality control processes for CRO deliverables and internal outputs, including datasets and TLFs.
• Partner with Biostatistics, Clinical Data Management, and other stakeholders to align standards and infrastructure with clinical development needs.
• Serve as subject matter expert for programming standards during audits and regulatory inspections.
• Lead and mentor a team of statistical programmers and standards specialists.
• Manage resource allocation, training and career development for team members.
• Identify emerging technologies and best practices to advance programming capabilities.
• Champion process improvements and standardization initiatives across the organization.

SUPERVISORY RESPONSIBILITIES :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education :

Experience :

Knowledge, Skills and Abilities :

Work Environment / Physical Demands :

Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $198,000 - $281,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.