Senior Director, Head of Clinical Statistical Programming

Role Summary

Senior Director, Head of Clinical Statistical Programming leads the Statistical Programming Organization within the Data Science Department. They oversee statistical programming activities across Clinical Development, manage regulatory submission activities to health authorities worldwide, and maintain programming infrastructure and SOP compliance. They drive automation of programming workflows in partnership with the Enterprise R&D AAAI organization and provide direct line management to regular and contract programmers.

Responsibilities

• Lead, manage, develop, support and mentor statistical programming group within the Data Science Department.
• Represent Clinical Statistical Programming and Data Science in cross-functional projects and processes inside and outside Jazz.
• Lead and oversee development and implementation of programming standards and practices to ensure alignment between the department’s strategic direction and the company’s R&D strategies.
• Oversee the development and implementation of statistical programming SOPs and work instructions, including program validation and documentation.
• Anticipate resource needs and work with management to ensure adequate resource allocation for all projects.
• Participate in vendor qualification/selection and monitor vendor performance.
• Provide programming leadership for preparation of datasets and TLFs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies.
• Ensure that the filing of study documentation is maintained to the standard required and is acceptable for audit.
• Assume direct line management responsibility of the clinical statistical programmers.
• Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using specifications, if warranted.
• Provide secondary reviews of Clinical Statistical Programming deliverables, if warranted.
• Promote collaborations and build teamwork spirit within the department and cross-functionally.
• Keep abreast of literature and advancements in SAS, R, Python and emerging programming languages.
• Oversee the automation and implementation of AI in the statistical programming workflow.

Qualifications

• 10+ years of statistical programming experience in the Pharmaceutical/Biotech Industry or CRO with 7+ years of supervisory experience.
• Experience leading submissions to worldwide regulatory agencies (FDA, EMA, PMDA, etc.).
• Demonstrated strong leadership qualifications, including strategic thinking, contingency planning, problem solving, and dispute resolution skills.
• Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
• Clear and effective verbal and written communications across disciplines in the company.
• Extensive experience managing CROs or FSPs to scale up or down as the workload permits.
• Good knowledge of drug development regulations pertinent to statistical analysis.
• Solid experience with global clinical trial practices, procedures, and methodologies.
• Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
• Excellent SAS programming skills.
• Must be highly motivated and able to work well under pressure and shifting priorities independently as a team leader and as a team member.
• Responsible for providing programming leadership for preparation of datasets and TLFs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies.

Education

• Bachelor’s Degree is required or a Master’s Degree or higher is preferred in Statistics, Mathematics, or related fields.