Job Details

Job Description

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

How you'll make an impact

• As the Director of Statistical Programming, you will lead teams of programmers to develop, test, validate, document, maintain and execute programs in SAS to support statistical deliverables within agreed timelines. You will mentor and develop programmers and allocate statistical programming resources under the provided project priorities and timelines.
• Facilitate talent management activities including hiring, training, staff development and succession planning. Mentor the team of programmers by providing regular coaching and guidance. Manage people resource allocation of statistical programming.
• Prepare, document, and review programming codes and outputs for own and other projects to ensure quality.
• Review ADS specs and outputs for projects.
• Ensure analysis data and programming code meet regulatory and company standards and are consistently structured for efficient programming, reporting, and review.
• Participate in development and adherence to procedures and standards.
• Prepare analysis datasets.
• Develop program specification and design documents.

What you'll need (Required)

• Master's Degree in Computer Science, Statistics, or related fields.
• 11 years of solid SAS programming experience on clinical data in the pharmaceutical and/or medical device industry.
• 3 years of experience managing statistical programmers.

What else we look for (Preferred)

• Proven successful project–management leadership skills.
• Proven expertise in SAS and Windows operating systems; experience with other software packages (e.g., R, S‑Plus).
• Proven expertise in MS Office Suite.
• Excellent written and verbal communication and interpersonal skills.
• Up-to-date knowledge of statistical developments and regulatory guidance.
• Expert understanding of clinical trial and statistical programming procedures, with ability to address issues beyond the team.
• Demonstrated track record in people management and coaching.
• Expert knowledge of regulatory guidelines (GCP, ICH, FDA, ISO) relevant to pharmaceutical/medical device research.
• Excellent problem‑solving, organizational, analytical, and critical‑thinking skills.
• Ability to manage employee relations, including hiring/firing authority and HR partnership.
• Experience facilitating change with management and executive stakeholders.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast‑paced environment.
• Teamwork orientation, including participation and presentation at meetings with internal and external representatives.
• Experience interacting with cross‑functional teams and leading cooperative efforts.

Benefits

We offer competitive salaries, performance‑based incentives, and a wide variety of benefit programs to meet the diverse individual needs of our employees and their families. The base pay range for this position is $182,000 to $257,000 (highly experienced). Salary will depend on factors such as location, qualifications, education, and prior experience.

Edwards is an Equal Opportunity/Affirmative Action employer, including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and healthcare providers. All patient‑facing and in‑hospital positions require COVID‑19 vaccination. If hired into a covered role, you will be required to submit proof of vaccination unless you request and receive a medical or religious accommodation. This requirement does not apply where prohibitively illegal.