Be an early applicantLess than 25 applicants

Company

Edwards Lifesciences · 7 hours ago

Senior Manager, Biostatistics

United States

Full-time

Remote

Senior Level, Lead/Staff

$190K/yr - $210K/yr

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BiotechnologyHealth Care

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Act as core team member/lead biostatistician of assigned clinical trial(s) in US and international/global trial

Accountable for clinical trials assigned to direct reports

Manage and oversee the work of small biostatistics team and may indirectly manage cross functional or matrix teams as appropriate.

Provide technical/statistical leadership to multiple and/or complex clinical projects in collaboration with cross-functional teams

Develop a robust talent development plan in alignment with functional growth strategies of the department

Develop and lead in the implementation of biostatistics strategies which may include negotiations with internal and external parties

Provide guidance on process improvement projects within biostatistics and cross-functional areas

Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization

Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams

Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement)

Make resource planning and budgetary recommendations on operational expenditure planning and other financial activities

Other incidental duties

Qualification

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. in BiostatisticsMaster's Degree in BiostatisticsClinical trial designStatistical programming (SAS)Statistical programming (R)FDA submission experienceEMEA submission experiencePMDA submission experienceProject managementMicrosoft Office SuiteCoaching

Required

Ph.D. or equivalent in Statistics, Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the requirements of the Associate Manager Required

Master's Degree or equivalent in Statistics, Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the requirements of the Associate Manager Required

Experience in clinical trial design, indication lead

FDA/EMEA/PMDA submission experience

The location for this position can be remote within the United States

Preferred

Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems

Expert understanding of related aspects of biostatistics processes and/or systems

Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

Dedicated to quality client service and pro-active and responsive to client needs.

Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team

Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

Participate and present at meetings with internal and external representatives

Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.

Develop relationships and leverage them to influence change

Support and solicit input from team members at all levels within the organization

Proficiency in statistical programming language such as SAS and/or R required

Strict attention to detail

Proven successful project management leadership skills

Proven expertise in both Microsoft Office Suite

Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

Promote a culture of collaboration and teamwork

Resolve operational and scheduling issues

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Benefits

Competitive salaries

Performance-based incentives

A wide variety of benefits programs to address the diverse individual needs of our employees and their families

Company

Edwards Lifesciences

Glassdoor

4.0

Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.

Founded in 1958

Irvine, California, USA

10,001+ employees

http://www.edwards.com

H1B Sponsorship

Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (36)

2022 (69)

2021 (53)

2020 (32)