Senior Statistical Programmer

Description

The company's MedTech business is hiring a Senior Statistical Programmer for its Circulatory Restoration portfolio.

The role sits in the Data Analytics and Computational Sciences function, within Biostatistics, in the Scientific/Technology category.

The Biostatistics team relies on this programmer to build and check analysis datasets and statistical outputs for clinical trials, put programming standards into practice, and advance CDISC-compliant datasets such as SDTM and ADaM across clinical programs.

The ideal candidate is detail-oriented, interested in clinical data analysis and regulatory processes such as PMA and 510(k) submissions, and keen to keep learning in a regulated setting.

The portfolio centers on intravascular lithotripsy (IVL), a treatment for complex calcified cardiovascular disease that the team develops and commercializes. The aim is a new standard of care for atherosclerotic cardiovascular disease, using local delivery of sonic pressure waves to treat calcified plaque.

Responsibilities

• Write and validate SAS programs that produce analysis datasets, tables, listings and figures (TLFs) for trial reports, regulatory submissions and publications.
• Run quality control and validation on datasets and outputs, whether built in-house or by external vendors, following company SOPs and good programming practice.
• Help draft and review programming specifications for SDTM and ADaM-style datasets based on CDISC standards and internal guidance.
• Build and maintain standard templates, macros and tools that keep studies consistent, efficient and compliant.
• Review Statistical Analysis Plans with biostatisticians to spot likely programming complications early.
• Work with statisticians, data managers, clinical staff and external vendors to deliver accurate work on time.
• Support data cleaning, interim analyses, medical review and final study reports with programming.
• Combine data across studies for pooled analyses, submission packages or visual summaries used in filings or internal strategy.
• Document your programming thoroughly so work can be reproduced and stays compliant in a validated environment.
• Use version control and structured documentation to keep work audit-ready and support shared programming.
• Contribute to posters, presentations and ad hoc analyses, including visual summaries built with SAS graphics or other visualization tools.
• Take on other duties as required.

Requirements

• Hold a bachelor's degree or higher in statistics, computer science, mathematics, life sciences or a related field.
• Have 5+ years of statistical programming experience in pharmaceuticals, biotechnology or medical devices.
• Be proficient in SAS, including Base, Macro and SQL, with exposure to SAS Graph and Stat procedures.
• Understand clinical trial design, GxP principles and FDA and EMA requirements, especially for medical device submissions such as PMA and 510(k).
• Know CDISC standards (SDTM, ADaM) and be able to build standardized datasets that meet internal and industry guidance.
• Bring strong attention to detail, problem-solving skills and the ability to work alone or in a team.
• Communicate clearly and collaborate well with cross-functional and cross-organizational teams.
• Required skills: computer programs, data analytics, statistical analysis and statistical interpretation.
• Preferred skills (a plus): experience with R or data visualization.
• Preferred skills: advanced analytics, analytical reasoning, biological sciences, biostatistics, clinical trials, data modeling, data privacy standards, data quality, data savvy, detail-oriented, good clinical practice (GCP), report writing, research ethics, researching, SAS programming, statistics and technology-savvy.

Conditions

The role is fully remote and can be based anywhere in the US. The posting location is listed as Santa Clara, California, United States of America.

Pay range for fully remote roles: US $92,000 - $148,350; Bay Area $106,000 - $170,200.

The anticipated base pay range for this position is $106,000.00 - $170,200.00.

Candidates who need an accommodation during the interview process can ask the company for one.

Benefits

• Eligible for the company's consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
• Eligible for the company's long-term incentive program.
• Time off, subject to policy and date of hire: vacation 120 hours per calendar year; sick time 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents); holiday pay including floating holidays 13 days per calendar year; work, personal and family time up to 40 hours per calendar year; parental leave 480 hours within one year of the birth, adoption or foster care of a child; bereavement leave 240 hours for an immediate family member or 40 hours for an extended family member per calendar year; caregiver leave 80 hours in a 52-week rolling period (10 days); volunteer leave 32 hours per calendar year; military spouse time off 80 hours per calendar year.
• Co-ops and interns are eligible for company-sponsored medical benefits per plan terms, up to 40 hours of sick time per calendar year (up to 56 hours for Washington residents), and the consolidated retirement plan (pension).
• This position is eligible for medical, dental, vision and time off benefits, plus any others provided under the applicable collective bargaining agreement.
• More general company benefits information is available on the company's careers benefits page.