Director, Statistical Programming

About the Company

Responsibilities

• ● Are you an experienced Manager and Leader in Statistical Programm ing with a deep knowledge of clinical drug development and line management experience Would you like to be part of a fast-paced and agile global team that has a direct strategic impact on drug development, empowered and trusted to innovate and experiment Join us at AstraZeneca Oncology Biometrics to impact a wide range of engaging projects striving to make a difference for millions of patients. Our Biometrics team consists of Statisticians, Programmer s and Information Scientists . We drive and contribute to optimized clinical drug development programs and access to information and scientific knowledge management. We are now offering an exciting opportunity for a dedicated and highly motivated individual to join us in the role as Statistical Programming Director, providing strategic programming leadership and line management within Onc Biometrics and collaborating with global product development teams . 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 proving 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
• ● + year s 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
• ● Ability to provide input to functional strategies
• ● 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.
• ● 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