Associate Director or Director, Statistical Programming

Kymera Therapeutics

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

Apply

Vacancy posted 5 days ago

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