Manager, Statistical Programming
Location
California
Posted
6 days ago
Salary
$158K - $227K / year
Seniority
Lead
Job Description
Manager, Statistical Programming
Penumbra, Inc.
• 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.
Job 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).
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