Natera
Director of Statistical Programming
US Remote
Role brief
What this role is asking for.
This is an exciting opportunity to lead Nateraโs Statistical Programming team, specifically focused on advancing our oncology portfolio through high-impact, practice-changing clinical trials. As a Director, you will provide strategic and technical oversight for all statistical programming activities supporting the clinical validation and utility of Nateraโs cutting-edge molecular diagnostics tests. The ideal candidate possesses a proven track record, strong leadership and communication skills, and a deep expertise in clinical trials, programming, and regulatory deliverables. PRIMARY RESPONSIBILITIES: Team Leadership : Build, mentor, and direct a high-performing statistical programming team, fostering technical excellence and overseeing their professional development. Functional Oversight: Provide strategic direction and standards for the programming function, securing alignment with oncology clinical development goals and department infrastructure needs. Submission Leadership: Act as the primary programming lead for regulatory submissions (e.g., 510(k), CTA/CDx, and PMA), ensuring all deliverables meet rigorous global standards. Analysis & Reporting: Direct the generation and validation of analysis datasets and TLFs, ensuring data integrity and regulatory compliance with ICH, GCP, and FDA 21 CFR Part 11. Development, Standards, and Validation: Lead the development, validation,...
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