Senior Manager, Statistical Programming

Edwards Lifesciences · Remote

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BiometricsRemoteFull-time$151k–$215kCompany career page

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Role summary

Edwards Lifesciences seeks a Senior Manager of Statistical Programming to lead a team overseeing statistical programming activities for clinical trials in transcatheter cardiac therapies. The role involves managing programmers, developing analysis datasets, ensuring regulatory compliance, and collaborating with cross-functional teams to support clinical evidence generation.

What they're looking for

Bachelor's degree in Statistics, Mathematics, Computer Science, or related field with 10 years statistical analysis experience; or Master's degree with 8 years regulated industry experience
Proven project management and leadership skills with demonstrated team management capability
Advanced proficiency in SAS and Windows operating systems; experience with R or S-Plus preferred
Expert knowledge of regulatory guidelines including GCP, ICH, FDA, and ISO standards in pharmaceutical/medical device research
Strong written and verbal communication with excellent problem-solving and critical thinking abilities
Class III medical device experience and familiarity with SDTM, ADAM, TLF standards preferred
Ability to manage competing priorities in fast-paced environment with strict attention to detail

What you'll be doing

Lead statistical programming team in developing program specifications and analysis datasets across multiple clinical trials
Manage small team of programmers and oversee cross-functional collaborations; develop talent development plans aligned with departmental growth
Provide programming expertise on complex clinical trial analyses, ad hoc data requests, and technical documentation for regulatory audits
Ensure analysis data and programming code meet regulatory and company standards with consistent structure across trials
Identify programming risks and lead implementation of mitigation strategies in collaboration with internal and external stakeholders

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