Job description

This position participates in the planning and execution of statistical tasks for assigned studies within a project under high level guidance from management or more senior level project statistician.

Key Responsibilities:
Develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies.

Develop statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses.

Review protocols and contribute to protocol statistical analysis sections, and generate study randomization scheme when appropriate.

Author results sections of the clinical study reports and supply statistical input for PMA submissions and in response to regulatory questions.

Provide independent validation of the statistical content in study documents including randomization, study reports, briefing documents, patient brochures, publications, and other content delivered to external entities.

Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.

Represent Biostatistics in study team and work with management and other team members regarding study status and timeline update.

Participate in developing case report forms and clinical database and data cleaning to ensure quality data collection.

Education and Experience:
Master's Degree or equivalent in Statistics, Biostatistics or related field , Plus 2 years previous analytical experience in clinical trials Required OR
Ph.D. or equivalent in Statistics, Biostatistics or related field Plus internship, senior projects, or thesis in Statistics, Biostatistics or related field Required

Additional Skills:
Must be proficient with SAS; proficiency with additional software packages such as R or S-Plus desired

Must have sound knowledge of theoretical and applied statistics.

Must have sound understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical/Medical Device research setting.

Effective skills in communication and team collaboration.

Proven expertise in SAS

Experience using other software packages (e.g., R, S-Plus)

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.

For California, the base pay range for this position is $111,000 to $157,000(highly experienced).

The pay for the successful candidate will depend on various factors (e.g., 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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