Computer programming Jobs in Irvine, CA

The Senior Director, Head of Clinical Statistical Programming leads the Statistical Programming Organization reporting into the VP of Data Science, Evidence and Value Generation and Global Medical and Scientific Affairs. The Sr Director is accountable for overseeing statistical programming activities for all Clinical Development studies. The Sr Director will also manage all regulatory submission activities to health authorities around the world for statistical programming. The Sr Director will also maintain programming infrastructure and ensure compliance with SOPs to produce quality and timely deliverables. The Sr Dir will be tasked with overseeing the automation of much of the statistical programming workflow in partnership with the Enterprise R+D AAAI organization. The Sr Director will use his/her strong people management skills to provide direct line management to regular and contract statistical programmers.

Essential Functions

• 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 and Jazz as well as outside of Jazz.
• Lead and oversee development and implementation of the programming standards and practices to ensure alignment between department’s strategic direction and 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
• Responsible for providing 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 according to processes 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

Required Knowledge, Skills, and Abilities

• 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

Required/Preferred Education and Licenses

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

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