Principal, Statistical Programmer
2 weeks ago
Imagine how your passion for data analysis and statistical programming can drive innovation in the medical field. At Edwards Lifesciences, we're pushing the boundaries of clinical evidence to demonstrate the effectiveness and safety of our life-changing technologies.
As a Principal, Statistical Programming, you'll be part of our Clinical Affairs team, working closely with principal investigators, medical professionals, and regulatory authorities to drive evidence-based decision-making. Your expertise in statistical programming will be instrumental in developing, testing, and validating programs in SAS, ensuring that our clinical trials meet the highest standards of quality and regulatory compliance.
Key Responsibilities:
- Develop and execute programs in SAS, serving as lead programmer and reviewer of junior-level programmers' work
- Provide programming expertise on clinical trials, including data analysis, documentation, and validation
- Lead in programming analysis datasets and ensure data meets regulatory and company standards
- Mentor and coach junior-level programmers, promoting knowledge sharing and skill development
- Collaborate with the Clinical Data Management team to review draft CRFs, databases, and perform edit checks
Requirements:
- Bachelor's Degree in Statistics, Mathematics, Computer Science, or related field, with 6 years of experience in statistical analysis
- Master's Degree or equivalent in Statistics, Mathematics, Computer Science, or related field, with 5 years of experience
- Ph.D. or equivalent in Statistics, Mathematics, Computer Science, or related field, with 2 years of experience
Preferred Qualifications:
- Proven expertise in MS Office Suite, including Word, PowerPoint, Access, and Excel
- Excellent written and verbal communication skills, with experience in negotiating and relationship management
- Keeps abreast of new developments in statistics and regulatory guidance
- Extensive understanding and knowledge of regulatory guidelines, including GCP, ICH, FDA, and ISO
Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer, committed to protecting our vulnerable patients and healthcare providers. As a condition of employment, you will be required to submit proof of COVID-19 vaccination, unless you request and are granted a medical or religious accommodation for exemption.
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