Senior Analyst, Statistical Programming

Edwards Lifesciences Gruppe; Redhill (MS); On-site; USD 119,000 - 168,000; Full time

Job summary

Edwards Lifesciences Gruppe seeks a Statistical Programmer to support clinical data analysis and reporting. You will develop analysis datasets, specifications, and output for submissions using SAS or R, ensuring compliance with regulatory standards.

The role requires a Statistics/Math/CS background with 2–4 years of statistical programming experience, plus strong communication and MS Office integration skills.

Qualifications

• Bachelor’s or Master’s degree in statistics, mathematics, computer science or related field.
• 2–4 years of statistical programming experience with SAS or similar tools.

Responsibilities

• Develop complex analysis datasets, specifications, and summary outputs for clinical reports or presentations.
• Create programs in SAS or R to support data analysis and regulatory submission requirements.
• Review and validate statistical programs and ensure documentation meets regulatory and company standards.

Skills

SAS

Statistics

R

MS Office integration

Education

Bachelor's degree in Statistics/Mathematics/Computer Science

Master's degree in Statistics/Mathematics/Computer Science

Tools

SAS

R

SQL

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 reviewReview 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 reviewPerform complex analysis in response to data requests in collaboration with designated statisticianCollaborate with CDM (Clinical Data Management) and designated statistician to review draft CRFs (Case Report Forms), database specifications, and perform edit checksOther duties assigned by leadershipWhat 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 orMaster's Degree or equivalent in Statistics, Mathematics, Computer Science or related field , 2 years experience previous statistical programming experience (e.g. SAS) RequiredWhat else we look for (Preferred):Proven expertise in interfacing MS Office Suite with SASGood written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skillsFull understanding and knowledge relevant to statistical programmingFull understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device settingStrong problem-solving, organizational, analytical and critical thinking skillsExperience working in clinical trials within a pharmaceutical/medical device industryGood leadership skills and ability to influence changeStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including inter-departmental teams and as key contact representing the organization on projectsAbility to interact with senior internal and external personnel on significant matters often requiring coordination between organizationsAdhere 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/controlAligning 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). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.