Director, Statistical Programming

AstraZeneca • Waltham, MA

1d

About The Position

Join AstraZeneca Oncology Biometrics as a Statistical Programming Director, providing strategic programming leadership and line management. This role is part of a fast-paced, agile global team with a direct strategic impact on drug development. The Biometrics team drives and contributes to optimized clinical drug development programs and information access. This position will work in the Early Oncology Programming group, managing and mentoring a group of programmers responsible for efficient delivery of studies (outsourced and internal), ensuring high-quality deliverables compliant with AZ and industry standards, SOPs, and GxP requirements. You will also contribute to the larger programming leadership team, engaging in activities beyond clinical trials, such as providing strategic or SME contributions on cross-functional teams to deliver continuous improvement, innovation, and automation solutions.

Requirements

• 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.
• 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.
• 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• Managing and mentoring a group of programmers.
• Ensuring 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.
• Providing strategic or SME contributions on cross-functional teams to deliver continuous improvement, innovation, and automation solutions.
• Leading and influencing teams.
• Initiating, leading and executing new initiatives and process improvements with cross-functional teams.
• Identifying, leading, and advancing talent.

Benefits

• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health coverage
• Dental coverage
• Vision coverage
• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree