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Director of Statistical Programming
NateraDirector of Statistical Programming leading statistical programming for oncology clinical trials at Natera. Providing strategic oversight for regulatory submissions and analysis datasets.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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.
- 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.
Requirements
What you’ll need- 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.
- Prior experience with NGS, genetics, and/or oncology molecular diagnostic testing a plus.
Benefits
Comp & perks- Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Free testing for Natera employees and their immediate families in addition to fertility care benefits.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Generous employee referral program.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Rstatistical programmingdata integrityregulatory complianceCDISC standardsSDTMADaMstatistical analysesprogramming maintenanceversion control
Soft Skills
mentoringteam leadershipproblem-solvingattention to detailcross-functional collaborationstrategic directionprofessional developmentcommunicationtechnical excellencefostering teamwork
Certifications
advanced degree in Biostatisticsadvanced degree in Statisticsadvanced degree in Computer Science