Director of Statistical Programming
Natera, Inc.
- New York, New York, United States
- New York, New York, United States
About
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.
Opportunity & Compensation Remote USA.
Compensation: $186,400 – $233,000 USD.
About Natera 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.
Benefits Competitive benefits: comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additional benefits include free testing, fertility care, pregnancy and baby bonding leave, 401(k) benefits, commuter benefits, and a generous employee referral program.
Equal Opportunity Employer Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, welcoming people of different backgrounds, experiences, abilities and perspectives.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
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Languages
- English
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