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.
KNOWLEDGE, SKILLS, AND ABILITIES:- 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
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
Remote USA
$186,400-$233,000 USD
