Director of Statistical Programming

Natera

10h • Remote

About The Position

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.

Requirements

• 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.
• 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

Nice To Haves

• Prior experience with NGS, genetics, and/or oncology molecular diagnostic testing a plus

Responsibilities

• Build, mentor, and direct a high-performing statistical programming team, fostering technical excellence and overseeing their professional development.
• Provide strategic direction and standards for the programming function, securing alignment with oncology clinical development goals and department infrastructure needs.
• Act as the primary programming lead for regulatory submissions (e.g., 510(k), CTA/CDx, and PMA), ensuring all deliverables meet rigorous global standards.
• 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.
• 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).
• Lead the development and maintenance of scalable programming infrastructure for the larger Biostatistics department.
• Partner with Biostatistics, Clinical Operations, Data Management, and Regulatory to integrate programming expertise into clinical study execution.

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k benefits.
• Commuter benefits.
• Generous employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees