Director of Statistical Programming

🕒 Abril 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $186.400 - $233.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Natera

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2004

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Natera é líder global em tecnologia de testes de DNA livre de células (cfDNA), especializada em testes e diagnósticos genéticos não invasivos. As soluções inovadoras da empresa concentram-se em áreas como triagem pré-natal, detecção de câncer e monitoramento de transplantes de órgãos. Ao utilizar bioinformática avançada e análise de DNA, a Natera oferece a profissionais de saúde e pacientes informações essenciais para decisões médicas mais embasadas.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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.