Director, Statistical Programming

Responsibilities

• Oversee statistical programming activities for multiple clinical studies across various therapeutic areas.
• Serve as the Lead Programmer and Manager for specific compounds and indications.
• Develop and validate technical programming specifications for analysis datasets using CDISC SDTM and ADaM standards.
• Provide direct line management to statistical programmers, including performance reviews, mentoring, and career development.
• Manage department budgets, including quarterly, annual, and long-term forecasting.
• Collaborate with Biostatistics, Clinical Data Management, and Clinical Operations to ensure programming needs are met.
• Manage external provider contracts and ensure adherence to company SOPs and regulatory standards.

Requirements

• 10+ years of statistical programming experience within the CRO or Pharmaceutical industry.
• 7+ years of people or project management experience in the CRO or Pharmaceutical industry.
• Advanced SAS programming skills in a clinical and statistical data environment.
• Thorough understanding of industry standards including CDISC and 21CFR Part 11.
• Proven experience in a leadership capacity with a focus on talent development and resource management.
• Strong understanding of pharmaceutical clinical development and regulatory submission processes.
• Excellent verbal and written communication skills for a global environment.

Preferred Qualifications

• BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics, or a related field.
• Experience managing large external provider contract budgets.

About the Company

Alexion, an AstraZeneca company, is a global biopharmaceutical company focused on delivering life-changing therapies for people with rare diseases.