Manager, Statistical Programming

🕒 Julho 10

🏄 California – Remoto

🏄 California – Remote

💵 $158.000 - $227.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

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Penumbra, Inc.

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2004

🏥 Saúde

🏭 Manufatura

⚕️ Seguro de Saúde

Healthcare • Manufacturing • Healthcare Insurance

Penumbra, Inc. é uma empresa global de saúde focada no desenvolvimento de tecnologias inovadoras para ajudar pacientes no mundo inteiro. Especializada na produção de dispositivos médicos para condições neurológicas e vasculares, a Penumbra oferece produtos como dispositivos de trombectomia, cateteres de embolização e sistemas compatíveis com RM (ressonância magnética). A empresa é dedicada a avançar o cuidado ao paciente com soluções de software de próxima geração, como o Lightning Flash 2. 0, projetado para a remoção rápida de coágulos sanguíneos e o tratamento da embolia pulmonar. A Penumbra está comprometida em melhorar os desfechos de condições como AVC, aneurisma cerebral e infarto agudo do miocárdio (IAM), sustentada por evidências clínicas e por estratégias de crescimento voltadas a investidores.

Descrição

• Manage a team of statistical programmers engaged in medical device clinical research activities. • Provide statistical programming support for multiple projects. • Build relationships and promote collaboration across functions. • Ensure the quality, integrity, and timely delivery of programming deliverables supporting clinical studies, publications, and regulatory submissions. • Drive programming standards, process improvements, innovations, and continuous improvement. • Select, manage, train, and develop staff. • Lead resource planning for statistical programming team. • Oversee team effort related to derive data sets and programs, and analysis data set specifications. • Ensure consistency analysis of data sets following appropriate standards for clinical studies. • Develop and oversee the development of statistical code for clinical studies. • Ensure that all quality processes are followed. • Provide input into the development of CRFs and database designs. • Participate in the review of SAP and Shells. • Creation documentation for regulatory filings. • Monitor and quantify efficiency, accuracy, and timeliness of the group. • Ensure that appropriate concepts and techniques are implemented for clinical studies. • Work collaboratively with multiple stakeholders and develop appropriate contingency plans. • Lead the development of standard code (e.g., SAS, R, Python, Git) and the development of standard operating procedures. • Manage CROs and other outside vendors for statistical programming activities when appropriate.

🎯 Requisitos

• Bachelor’s degree in Statistics, Data Science, Computer Science, Mathematics, or related field with 8+ years of experience or equivalent combination of education and experience. • In-depth knowledge of statistical programming concepts and techniques related to medical devices or drug development is required. • Master’s or higher degree preferred in Statistics, Data Science, Computer Science, Mathematics, or related field with 6+ years of relevant experience. • 1+ years of experience in a supervisory role desired. • Strong leadership and interpersonal skills are highly desired. • Medical device, pharmaceutical, biotech, or other regulated industry experience desired. • Regulatory filing experience preferred. • Experience with clinical trials, including familiarity with expectations of regulatory agencies (e.g., FDA, PDMA) preferred. • Able to effectively represent the clinical statistical programming function in cross functional teams. • Able to accurately estimate the effort required for project related programming activities. • High degree of technical competence and communication ability, both oral and written. • Understanding of ICH guidelines and relevant regulatory requirements. • Excellent problem-solving skills, with a demonstrated ability to guide programmers. • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously. • High degree of accuracy and attention to detail. • Competent in statistical programming and Macro development.

🏖️ Benefícios

• A collaborative teamwork environment where learning is constant, and performance is rewarded. • The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. • A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).