Natera

Director of Statistical Programming

US Remote

Role brief

What this role is asking for.

This is an exciting opportunity to lead Nateraโ€™s 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 Nateraโ€™s 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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