Senior Manager, Statistical Programming

Edwards Lifesciences

. Lead clinical studies, manage a team, and oversee statistical programming activities .

Posted 9/24/2026full-timeRemote • California • United StatesSenior💰 $151,000 - $215,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in statistical programming and clinical trial management, with a strong focus on SAS, regulatory compliance, and team leadership. Proven ability to develop programming specifications, manage projects, and ensure data integrity across clinical studies.

Highest-signal resume keywords

SAS Programming ExpertiseStatistical AnalysisProject Management LeadershipRegulatory Guidelines KnowledgeTeam Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingClinical Trial ProceduresData AnalysisProgramming SpecificationsStatistical Analysis DatasetsSDTMADAMTLFMacrosRegulatory Compliance

Soft Skills

Excellent Communication SkillsInterpersonal Relationship SkillsProblem-Solving SkillsOrganizational SkillsAnalytical Skills

Tools & Technologies

SASMS Office SuiteWindows Operating SystemClinical Study ReportsData Management Systems

Industry Keywords

Class III Medical Device ExperienceGCPICHFDAISORegulated Industry

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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