Senior Director, Biostatistics Job at Edwards Lifesciences

Edwards Lifesciences Minneapolis, MN

$203,000 - $288,000 a year
Senior Director, Biostatistics - Transcatheter, Mitral and Tricuspid Therapies

Responsible for a team of biostatisticians and activities while ensuring the proper design, analysis, and presentation of clinical studies.

Key Responsibilities:
Direct biostatistics activities with overall responsibility of managing vendors, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through several managers and/or SMEs.

Develop a robust talent development and succession planning in alignment with functional growth strategies across the global biostatistics organization.

Build an effective team across the organization

Provide strategic clinical and statistical leadership to entire portfolio of business unit in collaboration with cross-functional areas (e.g., Clinical Affairs, Medical Affairs)

Mitigate/eliminate risk, direct and communicate highly complex biostatistics strategies which includes negotiations with internal and external parties

Analyze, formulate and present statistical recommendations to advise and guide executive level leadership; develop and deliver executive level communication

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

Plan and direct strategic activities including prioritizing and allocating resources for projects with overall responsibility for meeting business objectives.

Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, 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)

Other incidental duties

Education and Experience:
Ph.D. or equivalent in in Statistics, Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the requirements of the Sr Manager Required OR

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

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

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

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 direct teams 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

Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions

Strict attention to detail

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

Interacts with senior management, and others concerning matters of significance to the company

Conduct business and technical briefings for senior and top management and for external representatives

Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization

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

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

Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions

Develop relationships and leverage them to influence change

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

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

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

The base pay range for this position is $203,000 to $288,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice


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