Associate Director, Statistical Programming

Associate Director, Statistical Programming

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Summary

The Early Development, Associate Director, Statistical Programming, is responsible for all statistical programming aspects of one or more drug development programs or indication programs within the Early Development space.

As a program lead, the Associate Director ensures cross-functional collaboration within and outside AQS and decision-making for assigned trials/programs in drug lifecycle management. They oversee all aspects of programming, quality, and regulatory compliance, ensuring efficient execution and high-quality results.

Responsibilities

• Lead statistical programming activities for multiple clinical trials within a program or indication/disease area, with experience in areas such as Immunology, Cardiovascular & Metabolic Diseases, and Neuroscience.
• Coordinate activities of internal/external programmers, make strategic programming decisions, and develop scientific documentation with Biostatisticians.
• Allocate resources effectively within and across programs to meet organizational goals.
• Recruit, mentor, and conduct performance appraisals for statistical programmers.
• Build effective relationships with cross-functional teams, communicate deliverables, and manage timelines and resources.
• Maintain up-to-date knowledge of programming software (e.g., SAS/R) and industry standards (e.g., CDISC, eCTD, Define.xml).
• Represent SP in audits, inspections, Health Authority meetings, and external conferences.

Experience & Qualifications

• Deep understanding of clinical trial methodology, regulatory requirements, and GCP.
• BS/MS in life sciences, computer science, statistics, mathematics, or related field; fluency in English.
• Early development experience, preferably in Oncology.
• Proven leadership and collaboration skills in a global environment.
• Expertise in SAS or R programming, including development and validation of deliverables.
• Experience managing 6-15 programmers, either as a functional/operational manager or individual contributor.
• Knowledge of industry standards like CDISC and experience with large team coordination.
• At least 2+ years in a lead/program/project programming role, ideally over 10+ years of industry experience with 6+ years in a programming or statistical role, and 3+ years in leadership.

About The Role

This position offers an exciting opportunity to lead statistical programming efforts in early drug development at Novartis, contributing to innovative therapies and patient outcomes.

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