Senior Manager, Statistical Programming

🕒 September 24

🏄 California – Remote

🏄 California – Remote

💵 $151k - $215k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Lead clinical studies, manage a team, and oversee statistical programming activities • Lead programmers in developing program specifications and design documents with the project statistician • Lead programming of analysis datasets across multiple clinical trials • Serve as lead statistical programmer for specific projects as needed • Manage and oversee a team of statistical programmers and matrix teams as appropriate • Develop a talent development plan aligned with departmental functional growth strategies • Provide programming expertise for clinical-trial analyses used in clinical study reports, presentations, and select publications • Provide programming expertise for complex ad hoc data requests • Identify risks and lead implementation of mitigation strategies, including negotiations with internal and external parties • Ensure analysis data and programming code meet regulatory and company standards • Ensure databases and external data sources meet analysis requirements across clinical trials • Develop and revise statistical programming procedures or instructions • Assist in compiling technical documents for internal and external audits • Perform other duties assigned by Leadership • Collaborate with cross-functional teams, customers, functional peer-group managers, and internal and external representatives • Participate in and present at internal and external meetings

🎯 Requirements

• Bachelor's Degree in Statistics, Mathematics, Computer Science or related field with 10 years previous experience in statistical analysis, or Master's Degree with 8 years working in a regulated industry • Proven successful project management leadership skills • Proven expertise in SAS and Windows operating systems • Class III Medical Device Experience preferred • SDTM, ADAM, TLF, Macros Experience preferred • Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel preferred • Excellent written and verbal communication skills and interpersonal relationship skills, including negotiating and relationship management skills • Ability to drive achievement of objectives • Keeps abreast of new developments in statistics and regulatory guidance • Expert understanding of clinical trial and statistical programming procedures • Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to pharmaceutical/medical device research • Demonstrated track record in people management • Excellent problem-solving, organizational, analytical, and critical thinking skills • Demonstrated ability to manage an assigned team and provide coaching and feedback, including hire/fire authority and partnering with HR on employee relations • Experience facilitating change and collaborating with management and executive stakeholders • Ability to interact professionally with all organizational levels • Ability to manage competing priorities in a fast-paced environment • Ability to work in a team environment, including participating and presenting at meetings with external representatives • Ability to adhere to company rules and requirements, including pandemic protocols and Environmental Health & Safety rules • Ability to prevent injuries and pollution within area of influence/control

🏖️ Benefits

• Competitive salaries • Performance-based incentives • Wide variety of benefits programs to address the diverse individual needs of employees and their families