Director of Statistical Programming

Role Description

This is an exciting opportunity to lead Natera’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 Natera’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, and review of efficient R code to support statistical analyses and deliverables. Enforce departmental standards for programming maintenance and code integrity. Facilitate cross-functional standards (eCRF design, DMPs).
• Infrastructure: Lead the development and maintenance of scalable programming infrastructure for the larger Biostatistics department.
• Interdisciplinary Partnership: Partner with Biostatistics, Clinical Operations, Data Management, and Regulatory to integrate programming expertise into clinical study execution.

Qualifications

• Minimum 10 years of relevant industry experience supporting clinical trials in diagnostics, biotechnology, pharmaceuticals, or related industries.
• At least 5 years leading a team.
• Advanced degree in Biostatistics, Statistics, Computer Science, or a related field.

Requirements

• Expert working knowledge of R for clinical trial reporting; experience maintaining statistical packages and computing environments under version control.
• In-depth knowledge of CDISC standards including SDTM and ADaM.
• Proven track record of producing high-quality analysis output for regulatory audiences (FDA) and internal stakeholders.
• Proven record of hiring, mentoring, and developing a successful, productive team.
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds.
• Exceptional problem-solving skills and attention to detail.
• Prior experience with NGS, genetics, and/or oncology molecular diagnostic testing a plus.

Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Natera employees and their immediate families receive free testing in addition to fertility care benefits.
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits, and much more.
• Generous employee referral program!

Company Description

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.