About the Role

As a Principal Biostatistician, you will lead statistical analyses for clinical trials, collaborate with stakeholders for new product development and regulatory submissions, and ensure data quality and compliance. You will also contribute to the development of Biostatistics processes and procedures, and provide statistical expertise for ad hoc analyses and publications.

About You

Required:

Ph.D. or equivalent in Statistics, Biostatistics, or related field with 2 years’ experience.

Preferred:

Survival analysis experience.
Proven expertise in SAS.
Experience using other software packages (e.g., R, S-Plus).
Experience with Statistical Analysis Plans (SAP).
Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel.
Excellent written and verbal communication skills and interpersonal relationship skills.
Extensive understanding of statistical methodologies related to clinical trial designs.
Knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to Pharmaceutical/Medical Device research.

Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.

Principal Biostatistician

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Summary

About the Role

About You

Benefits