Associate Director or Director, Statistical Programming

Kymera Therapeutics seeks an experienced Associate Director or Director of Statistical Programming to lead programming efforts across multiple clinical studies for a targeted protein degradation compound. This role requires strategic oversight of in-house and external programming teams, ensuring regulatory compliance and high-quality statistical deliverables throughout the development pipeline.

Responsibilities

• Lead statistical programming strategy, timelines, and resource planning for compound-level programs across multiple studies
• Manage in-house programming team and oversee CRO vendors delivering SDTM, ADaM, and TLF outputs
• Write specifications and develop, validate, and maintain datasets supporting data review, clinical study reports, and publications
• Coordinate data review processes and manage blinded data access during double-blind periods with PK/PD function
• Support regulatory submissions including Define-XML, ADRG, SDRG, and eCTD preparation

Requirements

• 8+ years statistical programming experience in pharmaceutical or biotechnology industry
• Deep knowledge of clinical trial conduct, data flow, and regulatory expectations
• Proficiency with SDTM, ADaM, and TLF development and validation
• Experience managing CROs and external vendors for statistical programming deliverables
• Strong cross-functional collaboration and strategic project leadership skills
• Experience with blinded data management and Define-XML/regulatory submissions