Director, Statistical Programming

AstraZeneca•Waltham, MA
•$168,830 - $253,246

About The Position

AstraZeneca Oncology Biometrics is seeking a Statistical Programming Director to provide strategic programming leadership and line management within Oncology Biometrics, collaborating with global product development teams. The role is part of the Early Oncology Programming group and supports a large, diverse portfolio of Phase 1 and Phase 2 trials across multiple oncology indications and mechanisms of action. The Director manages and mentors programmers responsible for efficient delivery of outsourced and internally delivered studies, ensuring high-quality outputs that comply with AstraZeneca and industry standards, SOPs, and GxP requirements. As part of the broader Oncology Programming leadership team, the role also contributes strategic or subject-matter expertise to cross-functional initiatives beyond clinical trials, including continuous improvement, innovation, and automation solutions.

Requirements

  • Minimum bachelor's degree in mathematics, statistics, computer science, life science, public health, or equivalent experience.
  • At least 10 years of experience, with advanced knowledge of the clinical development process and industry standards.
  • At least 7 years of people and/or project management experience.
  • Advanced SAS programming skills in a clinical and statistical data environment.
  • Demonstrated programming leadership, including the ability to develop teams and individuals and lead them toward 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 leadership experience focused on identifying, leading, and advancing talent.
  • Experience in a clinical development organization supporting multiple ongoing projects.
  • Thorough understanding of pharmaceutical clinical development, including statistical concepts, techniques, and clinical trial principles, and ability to manage and lead regulatory submissions.
  • Thorough understanding of industry standards such as CDISC and 21 CFR Part 11.
  • Strong problem-solving skills and ability to recommend 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 initiatives and process improvements.
  • Ability to recognize behaviors that align with AstraZeneca's values and support its employees, mission, and business objectives.

Nice To Haves

  • Broad experience, ideally across multiple therapeutic areas and outside Statistical Programming.
  • Previous oncology experience, ideally in both hematologic malignancies and solid tumors.
  • Knowledge or experience using open-source tools 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

  • Provide strategic statistical programming leadership within Oncology Biometrics and collaborate with global product development teams.
  • Manage and mentor a group of programmers responsible for delivery across a diverse portfolio of Early Oncology Phase 1 and Phase 2 trials.
  • Ensure efficient delivery and high quality of outsourced and internally delivered studies in compliance with AstraZeneca and industry standards, SOPs, and GxP requirements.
  • Contribute to the broader Oncology Programming leadership team.
  • Provide strategic or subject-matter expertise on cross-functional teams working on continuous improvement, innovation, and automation.
  • Lead and manage regulatory submissions.
  • Develop teams and individuals and lead them toward common goals.
  • Manage project scope, resources, finances, planning, and resource allocation.
  • Initiate, lead, and execute cross-functional initiatives and process improvements.

Benefits

  • Eligibility for short-term incentive bonuses.
  • Equity-based awards for salaried roles.
  • Qualified retirement programs.
  • Paid time off, including vacation, holidays, and leaves.
  • Health coverage.
  • Dental coverage.
  • Vision coverage.
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