Director of Statistical Programming

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

💵 $186.400 - $233.000 / Jahr

⏰ Vollzeit

🔴 Experte

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Natera

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2004

🧬 Biotechnologie

⚕️ Krankenversicherung

💊 Pharmazie

Biotechnology • Healthcare Insurance • Pharmaceuticals

Natera ist ein weltweit führendes Unternehmen in der Technologie der zellfreien DNA-Tests, das sich auf nicht-invasive genetische Tests und Diagnostik spezialisiert hat. Die innovativen Lösungen des Unternehmens konzentrieren sich auf Bereiche wie pränatales Screening, Krebstestung und Überwachung von Organtransplantationen. Durch den Einsatz fortschrittlicher Bioinformatik und DNA-Analysen bietet Natera medizinischen Fachkräften und Patienten entscheidende Informationen, um fundiertere medizinische Entscheidungen treffen zu können.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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.