Senior Analyst, Statistical Programming

Edwards Lifesciences Gruppe; United States; On-site; USD 119,000 - 168,000; Full time

Benefits offered by this job

Competitive salary

Incentives

Benefits program

Job summary

Edwards Lifesciences is seeking a Statistical Programmer for the Transcatheter Mitral and Tricuspid Therapies (TMTT) unit to support regulatory submissions and clinical reports. You will develop analysis datasets and outputs, create complex programs in SAS/R, and ensure documentation meets GCP/ICH/FDA/ISO standards.

Required: a Bachelor’s in Statistics, Mathematics, CS (4 years) or a Master’s with 2 years experience in statistical programming; strong MS Office integration with SAS; excellent

Qualifications

• Bachelor’s degree in Statistics, Mathematics, Computer Science or related field; 4 years of statistical programming experience (SAS).
• Master’s degree or equivalent; 2 years statistical programming experience (SAS).
• Experience interfacing MS Office with SAS; strong communication and collaboration skills.

Responsibilities

• Supports statistical programming activities and business outcomes.
• Develops analysis datasets, specifications, and outputs for clinical reports/presentations.
• Creates programs using SAS/R to meet regulatory and company standards.

Skills

Statistical programming

SAS

Data analysis

Communication

Team collaboration

Education

Bachelor's degree in Statistics/Mathematics/CS

Master's degree in Statistics/Math/CS

Tools

SAS

R

MS Office

Job description

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you’ll make an impact:

• Applies professional expertise and judgment to support statistical programming activities and business outcomes.
• Develop complex analysis datasets, specifications, and summary output (tables, listings, or graphs) for inclusion in clinical reports or presentations;
• Create complex programs that meet regulatory and company standards utilizing statistical programming languages (e.g. SAS, R) to permit efficient programming, reporting, and review
• Review and validate statistical programs and ensure that all appropriate program documentation and validation meets regulatory and company standards and consistently is structured to permit efficient programming, reporting, and review
• Perform complex analysis in response to data requests in collaboration with designated statistician
• Collaborate with CDM (Clinical Data Management) and designated statistician to review draft CRFs (Case Report Forms), database specifications, and perform edit checks
• Other duties assigned by leadership

What you’ll need (Required):

• Bachelor's Degree in Statistics, Mathematics, Computer Science or related field, 4 years experience previous statistical programming experience (e.g. SAS) Required
• Master's Degree or equivalent in Statistics, Mathematics, Computer Science or related field , 2 years experience previous statistical programming experience (e.g. SAS) Required

What else we look for (Preferred):

• Proven expertise in interfacing MS Office Suite with SAS
• Good written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
• Full understanding and knowledge relevant to statistical programming
• Full understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device setting
• Strong problem-solving, organizational, analytical and critical thinking skills
• Experience working in clinical trials within a pharmaceutical/medical device industry
• Good leadership skills and ability to influence change
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and as key contact representing the organization on projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• 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 $119,000 - $168,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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

Edwards Lifesciences 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.