Director, Statistical Programming

Accountabilities

This position will work in the Early Oncology Programming group and will be accountable for a large and diverse portfolio of products that cover phase 1 / 2 trials in various mechanisms of action and covering multiple indications within oncology. You will be responsible for managing and mentoring a group of programmers who are in turn accountable for efficient delivery on studies that are both outsourced and delivered internally, ensuring high-quality of deliverables while complying with AZ and industry standards, SOPs and GxP requirements. You will also be part of the larger programming leadership team within oncology programming, and responsible for various activities beyond clinical trials, such as providing strategic or SME contributions on cross-functional teams to deliver continuous improvement, innovation, and automation solutions.

Essential Skills/Experience

• Minimum bachelor's degree in mathematics (e.g., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science, Public Health or equivalent experience
• Minimum 10 years of experience with advanced knowledge of the clinical development process and industry standards
• 7+ years people and or project management experience
• Advanced SAS programming skills in a clinical and statistical data environment
• Demonstrated programming leadership capability with ability to develop teams and individuals and lead them towards a common goal
• Demonstrated influencing, planning and organizational skills
• Strong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation
• Significant experience in leadership capacity with a focus on identifying, leading, and advancing talent.
• Experience working in a clinical development organization with a heavy emphasis on support of multiple, ongoing projects
• Thorough understanding of pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.
• Thorough understanding of industry standards such as CDISC and 21CFR Part 11.
• Strong ability to solve problems, recommend process improvements, and execute process improvements.
• Ability to lead and influence teams
• Excellent verbal and written communication skills in a global environment.
• Proven ability to work with cross functional teams, specifically Data Management, Biostatistics, Epidemiology, Clinical Operations, and Pharmacovigilance to initiate, lead and execute new initiatives and process improvements.
• Recognize behaviors that align with our values critical to the success of our employees, mission, and business objectives.

Desirable Skills/Experience

• Broad experience, ideally across multiple therapeutic areas and outside of the field of Statistical Programming
• Previous oncology experience, ideally in both heme and solid tumor
• Knowledge / experience using open source and/or AI in Statistical Programming
• Experience in regulatory submissions and interactions
• Demonstrated experience designing and implementing business processes
• Willingness and ability to travel