Team Lead – Statistical Programming

JOB DESCRIPTION

Job Summary:

We are looking for an experienced Team Lead – Statistical Programming to lead statistical programming initiatives within the Pharmaceutical/Bio-Pharma domain. The ideal candidate will have strong expertise in clinical data standards, statistical programming workflows, and enterprise architecture, with the ability to design scalable solutions using AWS best practices. This role requires collaboration with cross-functional teams to deliver high-quality, compliant, and efficient statistical programming solutions.

Key Responsibilities:

• Lead and mentor the statistical programming team in delivering clinical trial programming activities.
• Develop and validate ADaM datasets, Tables, Listings, and Figures (TLFs) in compliance with CDISC and regulatory standards.
• Analyze current-state architecture and design scalable target-state solutions aligned with the AWS Well-Architected Framework.
• Evaluate enterprise systems and define integration strategies to improve interoperability and performance.
• Collaborate with Biostatistics, Clinical Data Management, and other stakeholders to gather requirements and deliver technical solutions.
• Drive process improvements, automation initiatives, and adherence to programming best practices.
• Participate in Agile/Scrum ceremonies and ensure timely project delivery.
• The ideal candidate should be comfortable working in an Agile/Scrum environment.

Required Skills & Qualifications:

• Strong experience in Statistical Programming within the Pharmaceutical/Life Sciences domain.
• Expertise in Statistical Programming workflows, TLF generation, ADaM datasets, and Scientific Computing Environment (SCE).
• Experience with the AWS Well-Architected Framework and enterprise integration architecture.
• Good understanding of CDISC standards (SDTM/ADaM) and regulatory requirements.
• Hands-on experience with SAS and/or other statistical programming tools.
• Excellent analytical, leadership, and communication skills with experience leading Agile teams.
• Bachelor’s or Master’s degree in Statistics, Computer Science, Life Sciences, or a related field.