Manager, Statistical Programming

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🔥 1 minute ago

🏄 California – Remote

🏄 California – Remote

💵 $158k - $227k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

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Penumbra, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

Penumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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).