Director, Statistical Programming

AstraZeneca•Waltham, MA

2d•$168,830 - $253,246•Hybrid

About The Position

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.

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 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.
Identifying, leading, and advancing talent.